Trial Outcomes & Findings for Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) (NCT NCT04582864)

NCT ID: NCT04582864

Last Updated: 2024-12-06

Results Overview

* Complete remission without minimal residual disease (CRmrd): CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC * Complete remission (CR): Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); platelet count ≥100 × 10\^9/L (100,000/µL), transfusion independence * CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 × 10\^9/L \[1000/µL\]) or thrombocytopenia (\<100 × 10\^9/L \[100,000/µL\])

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: At the end of Cycle 1 (each cycle is 28 days)
• Results posted on: 2024-12-06

Participant Flow

Participant milestones

Measure	Flotetuzumab * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Flotetuzumab * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Overall Study Did not complete cycle 1 due to disease progression	2
Overall Study Death	1

Baseline Characteristics

Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

Baseline characteristics by cohort

Measure	Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression).

• Complete remission without minimal residual disease (CRmrd): CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC
• Complete remission (CR): Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); platelet count ≥100 × 10^9/L (100,000/µL), transfusion independence
• CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL])

Outcome measures

Measure

Flotetuzumab n=10 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Efficacy as Measured by Number of Participants With CR(Mrd), CR, and CRi

0 Participants

SECONDARY outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 and 2 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment.

• Complete remission (CR): Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10^9/L (1000/µL); platelet count ≥100 × 10^9/L (100,000/µL), transfusion independence
• CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100,000/µL])

Outcome measures

Measure

Flotetuzumab n=2 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Efficacy as Measured by Number of Participants With CR and CRi

0 Participants

SECONDARY outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment (or Cycle 1 Day 28 assessment for patients who only received Cycle 1 of treatment).

• Defined as partial remission or better
• PR: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%

Outcome measures

Measure

Flotetuzumab n=9 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Overall Response Rate

0 Participants

SECONDARY outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment (or Cycle 1 Day 28 assessment for patients who only received Cycle 1 of treatment).

• MLFS: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required

Outcome measures

Measure

Flotetuzumab n=9 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Morphologic Leukemia-free State (MLFS) Rate

0 Participants

SECONDARY outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment (or Cycle 1 Day 28 assessment for patients who only received Cycle 1 of treatment).

• PR: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%

Outcome measures

Measure

Flotetuzumab n=9 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Partial Remission (PR) Rate

2 Participants

SECONDARY outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment (or Cycle 1 Day 28 assessment for patients who only received Cycle 1 of treatment).

• SD: Absence of CR(mrd), CR, CRi, PR, MLFS; and criteria for PD not met

Outcome measures

Measure

Flotetuzumab n=9 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Stable Disease (SD) Rate

3 Participants

SECONDARY outcome

Timeframe: Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)

Population: Protocol defined evaluability for participants is defined as completing all Cycle 1 infusions of flotetuzumab (or discontinued treatment due to drug toxicity or disease progression) and undergone Cycle 2 Day 28 disease assessment (or Cycle 1 Day 28 assessment for patients who only received Cycle 1 of treatment).

• PFS will be calculated as the time from the start of the first dose of study drug until the occurrence of disease progression or death from any cause, respectively
• Progressive disease: Evidence for an increase in bone marrow blast percentage (>50% over baseline), and/or increase of absolute blast counts in the blood (>50% to >25 × 10^9/L) without differentiation syndrome, or new extramedullary disease

Outcome measures

Measure

Flotetuzumab n=9 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Progression-free Survival (PFS) Rate

1.14 months Interval 0.79 to 2.49

SECONDARY outcome

Timeframe: Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

-OS will be calculated as the time from the start of the first dose of study drug until the occurrence of death from any cause.

Outcome measures

Measure

Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Overall Survival (OS)

2.66 months Interval 1.11 to 4.3

SECONDARY outcome

Timeframe: From start of treatment through 28 days following completion of treatment (median length of 59 days, full range 11-99 days).

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

Outcome measures

Measure	Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypotension	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 anemia	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 febrile neutropenia	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 sinus tachycardia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 adrenal insufficiency	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 anisocoria	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 conjunctivitis	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 scleral hemorrhage	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 blurred vision	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dry eye	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 melena	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 white tongue	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 abdominal distension	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 abdominal pain	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 abdominal pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 bloating	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 constipation	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 diarrhea	7 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dry mouth	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 esophageal pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 gastroesophageal reflux disease	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hemorrhoids	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 lower gastrointestinal hemorrhage	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 mucositis oral	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 nausea	5 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 stomach pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 vomiting	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 joint pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 chills	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 5 disease progression	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 edema face	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 edema face	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 edema limbs	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 facial pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 fatigue	9 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 fever	9 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 fever	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 generalized edema	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 injection site reaction	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 malaise	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 pain	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 GvHD of the gut	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 cytokine release syndrome	8 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 cytokine release syndrome	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 enterococcus	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2staphylococcus aureus	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 bacteremia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 enterocolitis infectious	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 lung infection	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 sepsis	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 sinusitis	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 viremia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 deep tissue injury	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 fall	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 infusion related reaction	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 activated partial thromboplastin time prolonged	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 alanine aminotransferase increased	7 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 alanine aminotransferase increased	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 alkaline phosphatase increased	5 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 alkaline phosphatase increased	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 aspartate aminotransferase increased	8 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 blood bilirubin increased	8 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 creatinine increased	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 INR increased	6 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 lymphocyte count decreased	10 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 neutrophil count decreased	7 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 platelet count decreased	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 weight gain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 white blood cell decreased	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 white blood cell decreased	8 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 anorexia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 anorexia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dehydration	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypercalcemia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hyperglycemia	6 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 hyperglycemia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hyperkalemia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 hyperkalemia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypermagnesemia	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypernatremia	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hyperphosphatemia	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypoalbuminemia	6 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 hypoalbuminemia	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypocalcemia	7 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 hypocalcemia	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypoglycemia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypokalemia	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hyponatremia	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypophosphatemia	9 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 finger stiffness	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 groin pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 groin swelling	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 knee pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 shoulder pain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 arthralgia	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 arthralgia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 back pain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 back pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 bone pain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 bone pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 flank pain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 generalized muscle weakness	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 neck pain	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 neck pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 pain in extremity	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 expressive aphasia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dizziness	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 dizziness	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dysgeusia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dysphasia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 headache	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 peripheral sensory neuropathy	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 somnolence	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 syncope	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 tremor	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 incoherent	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 mental status slightly altered	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 agitation	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 agitation	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 anxiety	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 confusion	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 confusion	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hallucinations	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 insomnia	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 restlessness	3 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 acute kidney disease	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dieresis	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 fractional excretion of sodium	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dysuria	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hematuria	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hemoglobinuria	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 proteinuria	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 urinary retention	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 sinus pressure	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 atelectasis	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 cough	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 dyspnea	5 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 dyspnea	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 epistaxis	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hypoxia	4 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 nasal congestion	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 productive cough	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 pulmonary edema	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 respiratory failure	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 sinus pain	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 sore throat	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 wheezing	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 oral lesion, left margin of tongue	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 acute GvHD	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 pain of skin	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 pruritus	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 rash maculo-papular	2 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 skin ulceration	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 flushing	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 1-2 hot flashes	1 Participants
Number of Participants With Adverse Events as Measured by CTCAE v5.0 Grade 3-5 hypotension	1 Participants

SECONDARY outcome

Timeframe: Through the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

• Grade 1:Symptoms are not life threatening and require symptomatic treatment only, e.g., fever, nausea, fatigue, headache, myalgias, malaise
• Grade 2: Symptoms require and respond to moderate intervention; oxygen requirement < 40% or hypotension responsive to fluids or low-dose of one vasopressor or grade 2 organ toxicity
• Grade 3: Symptoms require and respond to aggressive intervention; oxygen requirement ≥ 40% or hypotension requiring high-dose vasopressors or multiple vasopressors or grade 3 organ toxicity (except transaminitis) or grade 4 transaminitis
• Grade 4: Life-threatening symptoms; requirement for ventilator support or grade 4 organ toxicity (excluding transaminitis)
• Grade 5 Death

Outcome measures

Measure	Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus Guidelines Grade 1	1 Participants
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus Guidelines Grade 2	7 Participants
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus Guidelines Grade 3	3 Participants
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus Guidelines Grade 4	0 Participants
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus Guidelines Grade 5	0 Participants

SECONDARY outcome

Timeframe: Through the end of Cycle 2 (each cycle is 28 days)

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

Outcome measures

Measure

Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Number of Participants With Neurotoxicity as Measured by 2019 ASTCT Consensus Guidelines

4 Participants

SECONDARY outcome

Timeframe: Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

Outcome measures

Measure

Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Number of Participants With Acute Graft Versus Host Disease (GvHD) as Measured by MAGIC Criteria

1 Participants

SECONDARY outcome

Timeframe: Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)

Population: Protocol defined evaluability for participants is defined as having undergone any period of infusion of flotetuzumab.

Outcome measures

Measure

Flotetuzumab n=11 Participants * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.

Number of Participants With Chronic Graft Versus Host Disease (GvHD) as Measured by NIH Severity Score

1 Participants

Adverse Events

Flotetuzumab

Serious events: 8 serious events

Other events: 11 other events

Deaths: 10 deaths

Serious adverse events

Measure	Flotetuzumab n=11 participants at risk * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Blood and lymphatic system disorders Febrile neutropenia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Disease progression	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Immune system disorders Cytokine release syndrome	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Immune system disorders GvHD of the gut	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Sepsis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Sinusitis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Respiratory failure	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).

Other adverse events

Measure	Flotetuzumab n=11 participants at risk * Will start on cycle 1 day 1 on the dose escalation ramp schedule of flotetuzumab as a continuous intravenous (IV) infusion. Patients will be initiated at 30 ng/kg/day and have their dose increased daily to a target goal of 500 ng/kg/day by day 7 * Patients will continue on flotetuzumab at 500 ng/kg/day for the remaining 21 days of the 28 day cycle. * On cycle 1 day 28, patients will undergo bone marrow biopsy for assessment of disease status. Patients who have achieved a CR/CRi will proceed to a second cycle per protocol, while patients with a PR or SD or better may proceed to cycle 2 with permission of the investigator. Patients with available donor lymphocytes may receive DLI concurrently with flotetuzumab during Cycle 1 and/or Cycle 2.
Blood and lymphatic system disorders Anemia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Blood and lymphatic system disorders Febrile neutropenia	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Cardiac disorders Sinus tachycardia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Endocrine disorders Adrenal insufficiency	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Eye disorders Anisocoria	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Eye disorders Blurred vision	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Eye disorders Conjunctivitis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Eye disorders Dry eye	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Eye disorders Scleral hemorrhage	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Abdominal distension	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Abdominal pain	45.5% 5/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Bloating	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Constipation	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Diarrhea	63.6% 7/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Dry mouth	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Esophageal pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Gastroesophageal reflux disease	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Hemorrhoids	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Melena	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Nausea	45.5% 5/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Stomach pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders Vomiting	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Gastrointestinal disorders White tongue	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Chills	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Edema face	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Edema limbs	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Facial pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Fatigue	81.8% 9/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Fever	90.9% 10/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Generalized edema	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Injection site reaction	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Malaise	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
General disorders Pain	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Immune system disorders Cytokine release syndrome	90.9% 10/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Bacteremia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Enterococcus	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Enterocolitis infectious	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Lung infection	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Sepsis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Staphylococcus aureus	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Infections and infestations Viremia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Injury, poisoning and procedural complications Deep tissue injury	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Injury, poisoning and procedural complications Fall	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Injury, poisoning and procedural complications Infusion related reaction	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Activated partial thromboplastin time prolonged	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Alanine aminotransferase increased	72.7% 8/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Alkaline phosphatase increased	54.5% 6/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Aspartate aminotransferase increased	72.7% 8/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Blood bilirubin increased	72.7% 8/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Creatinine increased	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations INR increased	54.5% 6/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Lymphocyte count decreased	90.9% 10/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Neutrophil count decreased	63.6% 7/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Platelet count decreased	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations Weight gain	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Investigations White blood cell decreased	81.8% 9/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Anorexia	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Dehydration	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypercalcemia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hyperglycemia	63.6% 7/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hyperkalemia	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypermagnesemia	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypernatremia	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hyperphosphatemia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypoalbuminemia	81.8% 9/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypocalcemia	90.9% 10/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypoglycemia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypokalemia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hyponatremia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Metabolism and nutrition disorders Hypophosphatemia	81.8% 9/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Arthralgia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Back pain	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Bone pain	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Finger stiffness	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Flank pain	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Groin pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Groin swelling	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Joint pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Knee pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Neck pain	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Dizziness	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Dysgeusia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Dysphasia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Expressive aphasia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Headache	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Peripheral sensory neuropathy	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Somnolence	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Syncope	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Nervous system disorders Tremor	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Agitation	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Anxiety	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Confusion	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Hallucinations	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Incoherent	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Insomnia	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Mental status slightly altered	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Psychiatric disorders Restlessness	27.3% 3/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Acute kidney disease	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Dieresis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Dysuria	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Fractional excretion of sodium	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Hematuria	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Hemoglobinuria	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Proteinuria	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Renal and urinary disorders Urinary retention	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Atelectasis	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	54.5% 6/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Epistaxis	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Hypoxia	36.4% 4/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Productive cough	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Pulmonary edema	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Sinus pain	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Sinus pressure	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Respiratory, thoracic and mediastinal disorders Wheezing	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Acute skin GvHD (rash maculo-papular)	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Oral lesion, left margin of tongue	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Pain of skin	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Pruritis	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Skin and subcutaneous tissue disorders Skin ulceration	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Vascular disorders Flushing	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Vascular disorders Hot flashes	9.1% 1/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Vascular disorders Hypotension	45.5% 5/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).
Musculoskeletal and connective tissue disorders Shoulder pain	18.2% 2/11 • Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days).

Additional Information

Dr. Matthew Christopher

Washington University School of Medicine

Phone: 314-273-0286

Email: christopherm@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place