Trial Outcomes & Findings for Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303) (NCT NCT00201240)

NCT ID: NCT00201240

Last Updated: 2021-11-01

Results Overview

The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

6 months

Results posted on

2021-11-01

Participant Flow

Patients were recruited from October2005 through December 2008

Participant milestones

Participant milestones
Measure	T Cell Depletion T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
Overall Study STARTED	47
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Age, Customized <20	0 participants n=5 Participants
Age, Customized 20-29	7 participants n=5 Participants
Age, Customized 30-39	4 participants n=5 Participants
Age, Customized 40-49	14 participants n=5 Participants
Age, Customized 50-59	19 participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized White	42 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants
Karnofsky Performance Status 100%	17 participants n=5 Participants
Karnofsky Performance Status 90%	17 participants n=5 Participants
Karnofsky Performance Status 80%	8 participants n=5 Participants
Karnofsky Performance Status 70%	2 participants n=5 Participants
Leukemia stage CR1	37 participants n=5 Participants
Leukemia stage CR2	7 participants n=5 Participants
Cytogenetic risk Favorable	1 participants n=5 Participants
Cytogenetic risk Intermediate	28 participants n=5 Participants
Cytogenetic risk Unfavorable	14 participants n=5 Participants
Cytogenetic risk Unknown	1 participants n=5 Participants
Recipient CMV Status Positive	17 participants n=5 Participants
Recipient CMV Status Negative	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All transplanted patients

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Probability of Disease-free Survival (DFS) at 6 Months Post-transplant (Death or Relapse Will be Considered Events for This Endpoint)	81.8 percentage of patients Interval 70.3 to 93.4

SECONDARY outcome

Timeframe: Months 12 and 36

To assess the incidence of acute leukemia relapse from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval. Death prior to relapse will be considered as a competing risk.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Leukemia Relapse 36 months	23.7 percentage of participants Interval 10.5 to 37.0
Leukemia Relapse 12 months	20.6 percentage of participants Interval 8.4 to 32.8

SECONDARY outcome

Timeframe: 28 day

Time to neutrophil engraftment is measured by determining the first of three consecutive measurements of absolute neutrophil count ≥ 500/uL following conditioning regimen induced nadir, starting from Day 0.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Neutrophil Engraftment	12 days Interval 9.0 to 19.0

SECONDARY outcome

Timeframe: 6 Months

Time to platelet engraftment is measured by determining the first of three consecutive measurements of platelet count ≥ 20,000/uL without platelet transfusion support for seven days, starting from Day 0.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Platelet Engraftment	16 days Interval 13.0 to 159.0

SECONDARY outcome

Timeframe: Day 100

Primary graft failure is defined as the failure to achieve an ANC \> 500 cells/µL by Day +30. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in neutrophil counts \< 500 cells/µL, unresponsive to growth factor therapy.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Graft Failure Primary Graft Failure	0 participants
Graft Failure Secondary Graft Failure	1 participants

SECONDARY outcome

Timeframe: Day 100

Incidence and severity of acute GVHD will be graded according to the BMT CTN MOP.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Acute Graft Versus Host Disease (GVHD) Grades II - IV	22.7 percentage of participants Interval 10.2 to 35.3
Acute Graft Versus Host Disease (GVHD) Grades III - IV	4.5 percentage of participants Interval 0.0 to 10.8

SECONDARY outcome

Timeframe: Year 2

Incidence and severity of chronic GVHD will be scored according to the BMT CTN MOP.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Chronic Graft Versus Host Disease (GVHD) Limited/extensive	19.0 percentage of participants Interval 6.8 to 31.1
Chronic Graft Versus Host Disease (GVHD) Extensive only	6.8 percentage of participants Interval 0.0 to 14.4

SECONDARY outcome

Timeframe: Months 12, 24, and 36

Death occurring in a patient in continuing complete remission.

Outcome measures

Outcome measures
Measure	T Cell Depletion n=44 Participants T cell depletion using Miltenyi device for patients with AML in first or second complete remission
Transplant Related Mortality 12 months	14 percentage of participants Interval 3.4 to 24.0
Transplant Related Mortality 24 months	20 percentage of participants Interval 7.1 to 32.7
Transplant Related Mortality 36 months	23.2 percentage of participants Interval 9.3 to 37.1

Adverse Events

T Cell Depletion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Mendizabal, PhD

The Emmes Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place