Trial Outcomes & Findings for Adoptive Transfer of Haplo-identical DLI for AML and MDS (NCT NCT02046122)

NCT ID: NCT02046122

Last Updated: 2020-12-03

Results Overview

Unacceptable toxicity is defined as: i. Grade III or IV acute GVHD (aGVHD) of the gut or liver or Grade IV aGVHD of the skin lasting \> 7 days; ii. Grade IV Common Terminology Criteria for Adverse Events (CTCAE) toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting \>7 days iii. Treatment-related mortality (TRM)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

up to 8 weeks after last cell infusion

Results posted on

2020-12-03

Participant Flow

1 subject was a screen failure and 1 subject withdrew prior to starting study.

Participant milestones

Participant milestones
Measure	Idarubicin + Cytarabine + DLI Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Overall Study STARTED	17
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Idarubicin + Cytarabine + DLI Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Overall Study Physician Decision	8
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Adoptive Transfer of Haplo-identical DLI for AML and MDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Idarubicin + Cytarabine + DLI n=19 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Age, Continuous	71 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 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	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 weeks after last cell infusion

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=17 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Number of Subjects With Unacceptable Toxicity	1 Participants

SECONDARY outcome

Timeframe: one year following adoptive transfer

Population: Data not collected on one subject.

1 year disease free survival rate following adoptive transfer

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=16 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Disease Free Survival	3 Participants

SECONDARY outcome

Timeframe: 2 years after completing therapy

Population: Seventeen patients were enrolled between 2014 and 2017 with a median follow-up time of 299 days among all patients. One enrolled patient who developed sepsis during induction chemotherapy did not receive MST, and was excluded from final analysis of safety and efficacy.

Number of participants alive 2 years after completing adoptive transfer therapy.

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=16 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Overall Survival	16 participants

SECONDARY outcome

Timeframe: 8 weeks after last cell infusion

Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting \> 7 days

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=17 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Percentage of Subjects With Acute GVHD	0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks after the last cell infusion

Grade IV CTCAE toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting \>7 days, Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting \> 7 days, or death

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=17 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Percentage of Subjects With Unacceptable Toxicity	5.88 percentage of participants

SECONDARY outcome

Timeframe: 2 years after completing therapy

Population: Data not collected on one subject.

Efficacy as measured by the number of subjects with a complete remission. Responses were evaluated according to standard criteria defined by the National Comprehensive Cancer Network Guidelines for AML (www.nccn.org).

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=16 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Rate of Efficacy	10 Participants

SECONDARY outcome

Timeframe: up to 2 years after completing therapy

Population: Data not collected on one subject.

Immune recovery determined by measurements of cytokine profiles, lymphocyte and natural killer (NK) enumeration and flow-based assays, measured prior to induction, prior to each round of consolidation, 8 weeks after the last cycle of consolidation, and every 3 months after treatment for up to 2 years

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=16 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Number of Participants With Immune Recovery	3 Participants

SECONDARY outcome

Timeframe: 2 years after completion of therapy

Population: Data not collected on one subject.

Hematopoietic recovery as measured by the date of the first of three consecutive laboratory values where the absolute neutrophil count (ANC) ≥ 500/μl , the date of the first of three consecutive laboratory values obtained on different days where the platelet count was \> 20,000/μl without transfusion.

Outcome measures

Outcome measures
Measure	Idarubicin + Cytarabine + DLI n=16 Participants Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Number of Days to Hematopoietic Recovery Neutrophil recovery	29 days Interval 16.0 to 31.0
Number of Days to Hematopoietic Recovery Platelet recovery	32 days Interval 23.0 to 37.0

Adverse Events

Idarubicin + Cytarabine + DLI

Serious events: 8 serious events

Other events: 17 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Idarubicin + Cytarabine + DLI n=17 participants at risk Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Blood and lymphatic system disorders Febrile neutropenia	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Cardiac disorders Atrial fibrillation	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Gastrointestinal disorders Ileus	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Gastrointestinal disorders Mucositis oral	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
General disorders Multi-organ failure	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Hepatobiliary disorders Hepatic failure	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Psychiatric disorders Delirium	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.

Other adverse events

Other adverse events
Measure	Idarubicin + Cytarabine + DLI n=17 participants at risk Chemotherapy combined with adoptive transfer of HLA-haploidentical donor lymphocyte infusion (DLI) Idarubicin: Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy. Cytarabine: Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5. Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after
Respiratory, thoracic and mediastinal disorders Hypoxia	11.8% 2/17 • Number of events 3 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	11.8% 2/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Blood and lymphatic system disorders Anemia	76.5% 13/17 • Number of events 65 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Blood and lymphatic system disorders Blood and lymphatic system disorders other	23.5% 4/17 • Number of events 7 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Blood and lymphatic system disorders Febrile neutropenia	76.5% 13/17 • Number of events 21 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Cardiac disorders Atrial fibrillation	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Cardiac disorders cardiac disorders other	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Ear and labyrinth disorders Hearing impaired	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Eye disorders eye disorders other	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Gastrointestinal disorders Mucositis oral	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
General disorders Fatigue	17.6% 3/17 • Number of events 3 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Fever	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations general disorders and administration site conditions	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Infections and infestations other	11.8% 2/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Lung infection	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Penile infection	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Sepsis	35.3% 6/17 • Number of events 6 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Splenic infection	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Infections and infestations Urinary tract infection	17.6% 3/17 • Number of events 3 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations Blood bilirubin increased	11.8% 2/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations Creatinine increased	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations ECG QT corrected interval prolonged	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations Lymphocyte count decreased	5.9% 1/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations Neutrophil count decreased	64.7% 11/17 • Number of events 16 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations Platelet count decreased	100.0% 17/17 • Number of events 34 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Investigations White blood cell decreased	94.1% 16/17 • Number of events 28 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Acidosis	5.9% 1/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Alkalosis	5.9% 1/17 • Number of events 3 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Anorexia	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hyperglycemia	41.2% 7/17 • Number of events 18 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hyperkalemia	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hypoalbuminemia	41.2% 7/17 • Number of events 8 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hypocalcemia	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hypokalemia	64.7% 11/17 • Number of events 26 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hyponatremia	11.8% 2/17 • Number of events 4 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Hypophosphatemia	11.8% 2/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Metabolism and nutrition disorders Tumor lysis syndrome	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) treatment related secondary malignancy	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Nervous system disorders peripheral sensory neuropathy	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Nervous system disorders Syncope	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Renal and urinary disorders Acute kidney injury	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Renal and urinary disorders Hematuria	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders other	11.8% 2/17 • Number of events 2 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.9% 1/17 • Number of events 1 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Vascular disorders Hypertension	17.6% 3/17 • Number of events 4 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.
Vascular disorders Hypotension	17.6% 3/17 • Number of events 4 • All serious adverse events (SAEs) that occur up to 30 days after the last Donor Lymphocyte Infusion (DLI) will be reported. After 30 days, SAEs will be reported if thought related to treatment for the duration of the study. Non-treatment related SAEs were not collected past 30 days after the last DLI.

Additional Information

Anthony Sung, MD

Duke University

Phone: 919-668-1002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place