Trial Outcomes & Findings for Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia (NCT NCT00274846)

Results Overview

Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (\>100 donor-derived NK cells per uL of patient blood detectable at day +14).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Study Day 14

Results posted on

2017-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Relapsed/Refractory Acute Myeloid Leukemia Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Relapsed/Refractory Acute Myeloid Leukemia Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
Overall Study Did not receive adequate NK cells	1

Baseline Characteristics

Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Relapsed/Refractory Acute Myeloid Leukemia n=21 Participants Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 18.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Study Day 14

Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (\>100 donor-derived NK cells per uL of patient blood detectable at day +14).

Outcome measures

Outcome measures
Measure	Patients With Relapsed/Refractory AML - Evaluable Group n=20 Participants Patients who are evaluable; received adequate (dose of 1.5-8 x 10\^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
Number of Patients With Natural Killer (NK) Cell Expansion	2 Participants

SECONDARY outcome

Timeframe: Day 28-35

Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (\< 1% blasts in bone marrow with neutrophil recovery).

Outcome measures

Outcome measures
Measure	Patients With Relapsed/Refractory AML - Evaluable Group n=20 Participants Patients who are evaluable; received adequate (dose of 1.5-8 x 10\^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
Number of Patients With Complete Remission	2 Participant

SECONDARY outcome

Timeframe: From 1st Day of treatment until death or receipt of bone marrow transplant.

Population: Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint.

Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.

Outcome measures

Outcome measures
Measure	Patients With Relapsed/Refractory AML - Evaluable Group n=2 Participants Patients who are evaluable; received adequate (dose of 1.5-8 x 10\^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
Median Time to Disease Relapse (Months)	7.3 Months Interval 3.5 to 11.0

SECONDARY outcome

Timeframe: From Day 1 of Treatment until death or patient received bone marrow transplant.

Median number of months patients were alive after NK cell infusion.

Outcome measures

Outcome measures
Measure	Patients With Relapsed/Refractory AML - Evaluable Group n=2 Participants Patients who are evaluable; received adequate (dose of 1.5-8 x 10\^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
Overall Survival Time of Patients With Complete Remission	13 Months Interval 7.0 to 19.0

SECONDARY outcome

Timeframe: Day 14

Population: Unable to evaluate due to low complete remission rate.

Includes patients who had both a complete remission of disease and an expansion of natural killer cells.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Relapsed/Refractory Acute Myeloid Leukemia

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Relapsed/Refractory Acute Myeloid Leukemia n=21 participants at risk Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
General disorders Death due to progressive disease	66.7% 14/21 • Number of events 14 • Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion. All "other" adverse events that occurred were expected and not captured.
Blood and lymphatic system disorders Hemorrhage, CNS	4.8% 1/21 • Number of events 1 • Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion. All "other" adverse events that occurred were expected and not captured.
Blood and lymphatic system disorders Hemorrhage, lung	4.8% 1/21 • Number of events 1 • Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion. All "other" adverse events that occurred were expected and not captured.
Infections and infestations Infection	19.0% 4/21 • Number of events 4 • Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion. All "other" adverse events that occurred were expected and not captured.
Nervous system disorders Leukoencephalopathy	4.8% 1/21 • Number of events 1 • Events were monitored from Day 1 of study through Day 60 post-natural killer cell infusion. All "other" adverse events that occurred were expected and not captured.

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Miller, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-625-7409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place