Trial Outcomes & Findings for Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia (NCT NCT02807883)

Last Updated: 2023-01-20

Results Overview

Participants with treatment-related toxicities attributable to Blinatumomab. Toxicities defined as any 1) grade 3-4 acute GVHD greater than 30%, 2) secondary graft failure \>30%, or 3) nonrelapse mortality (NRM) within one cycle of Blinatumomab.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

30 days from the first cycle

Results posted on

2023-01-20

Participant Flow

Participants recruitment from August 2016 to June 2020 at MD Anderson Cancer Center

23 participants signed consents, 2 participants withdrew before treatment.

Participant milestones

Participant milestones
Measure	Blinatumomab Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Blinatumomab Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blinatumomab n=23 Participants Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 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
Region of Enrollment United States	21 participants n=5 Participants
Region of Enrollment Mexico	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days from the first cycle

Outcome measures

Outcome measures
Measure	Blinatumomab n=21 Participants Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Number of Participants With Toxicities	0 Participants

SECONDARY outcome

Timeframe: From last treatment cycle, assessed up to 1 year

Number of participants with progression free survival from the date of allogeneic HCT to the date of disease progression or death. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.)

Outcome measures

Outcome measures
Measure	Blinatumomab n=21 Participants Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Progression Free Survival (PFS)	15 Participants

SECONDARY outcome

Timeframe: From last treatment cycle, assessed up to 1 year

Number of participants in the study who are alive and disease free up to 1 year.

Outcome measures

Outcome measures
Measure	Blinatumomab n=21 Participants Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Overall Survival (OS)	18 Participants

Adverse Events

Blinatumomab

Serious events: 5 serious events

Other events: 20 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Blinatumomab n=23 participants at risk Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Blood and lymphatic system disorders Low granulocyte	17.4% 4/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Blood and lymphatic system disorders Secondary graft failure	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.

Other adverse events

Other adverse events
Measure	Blinatumomab n=23 participants at risk Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Blinatumomab: Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT). Hematopoietic Cell Transplantation: Hematopoietic progenitor cell infusion
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations ALK increased	13.0% 3/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Skin and subcutaneous tissue disorders Alopecia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations ALT increased	39.1% 9/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations Anemia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Psychiatric disorders Anxiety	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations AST increased	21.7% 5/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Infections and infestations Bacterial	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Cardiac disorders CD OTH	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Cardiac disorders Chest pain	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Psychiatric disorders Confusion	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Gastrointestinal disorders Constipation	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations Creatinine increased	8.7% 2/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Gastrointestinal disorders Diarrhea	30.4% 7/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Cardiac disorders Dysrhythmia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Nervous system disorders Dizziness	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Eye disorders Dry eye	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
General disorders Fatigue	17.4% 4/23 • Adverse event were collected up to 30 days from the last treatment cycle.
General disorders Fever	13.0% 3/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Nervous system disorders Headache	13.0% 3/23 • Adverse event were collected up to 30 days from the last treatment cycle.
General disorders Flu like syndrome	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Psychiatric disorders Insomnia	8.7% 2/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Blood and lymphatic system disorders Low granulocyte	26.1% 6/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Metabolism and nutrition disorders Hypokalemia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Respiratory, thoracic and mediastinal disorders Hiccups	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Metabolism and nutrition disorders Hypomagnesemia	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Vascular disorders Hypotension	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Skin and subcutaneous tissue disorders Rash	30.4% 7/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations Low platelet	17.4% 4/23 • Adverse event were collected up to 30 days from the last treatment cycle.
General disorders NE COR	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Gastrointestinal disorders Nausea	13.0% 3/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Gastrointestinal disorders Oral mucositis	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Vascular disorders Thromboembolic event	8.7% 2/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Infections and infestations Viral	8.7% 2/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Blood and lymphatic system disorders Secondary graft failure	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Nervous system disorders Tremor	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Investigations Wbc decreased	52.2% 12/23 • Adverse event were collected up to 30 days from the last treatment cycle.
Gastrointestinal disorders Vomiting	4.3% 1/23 • Adverse event were collected up to 30 days from the last treatment cycle.

Additional Information

Partow Kebriaei, MD / Stem Cell Transplantation Department

University of Texas MD Anderson Cancer Center

Phone: 713-745-0663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place