Trial Outcomes & Findings for AML Therapy With Irradiated Allogeneic Cells (NCT NCT02105116)
NCT ID: NCT02105116
Last Updated: 2021-08-24
Results Overview
Patients will be observed for incidence of adverse events related to experimental therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study because of failure to reach complete remission. None of the enrolled patients received experimental therapy (allogeneic donor lymphocyte therapy). The one death occurred while receiving standard therapy prior to eligibility for experimental allogeneic therapy. The remained of patients were ineligible for experimental therapy because they did not obtain a complete remission after standard induction chemotherapy.
TERMINATED
NA
6 participants
Up to 2 years
2021-08-24
Participant Flow
Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/17/2014 and was closed to accrual on 08/25/2015. The study was terminated on 12/16/2015.
We are reporting results on 6 eligible patients. One patient was deemed ineligible.
Participant milestones
| Measure |
Treatment (Combination Chemotherapy, DLI)
INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have \>5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.
ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10\^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.
fludarabine phosphate: Given IV
cytarabine: Given IV
donor lymphocytes: Undergo infusion of donor lymphocytes
laboratory biomarker analysis: Correlative studies
G-CSF: Given IV
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (Combination Chemotherapy, DLI)
INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have \>5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.
ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10\^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.
fludarabine phosphate: Given IV
cytarabine: Given IV
donor lymphocytes: Undergo infusion of donor lymphocytes
laboratory biomarker analysis: Correlative studies
G-CSF: Given IV
|
|---|---|
|
Overall Study
not eligible for step 2 of trial
|
5
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
AML Therapy With Irradiated Allogeneic Cells
Baseline characteristics by cohort
| Measure |
Treatment (Combination Chemotherapy, DLI)
n=6 Participants
INDUCTION CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have \>5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician.
ALLOGENEIC CELLULAR THERAPY: Patients undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10\^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.
fludarabine phosphate: Given IV
cytarabine: Given IV
donor lymphocytes: Undergo infusion of donor lymphocytes
laboratory biomarker analysis: Correlative studies
G-CSF: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 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
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 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
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPatients will be observed for incidence of adverse events related to experimental therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study because of failure to reach complete remission. None of the enrolled patients received experimental therapy (allogeneic donor lymphocyte therapy). The one death occurred while receiving standard therapy prior to eligibility for experimental allogeneic therapy. The remained of patients were ineligible for experimental therapy because they did not obtain a complete remission after standard induction chemotherapy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPatients' response rate will be determined by allogeneic cell therapy-related mortality. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPatients will be scored as being in continuous remission at 2 years or having relapsed sooner. Of the 6 patients enrolled, all were ineligible to enter the treatment phase of the study for failure to reach complete remission for allogenic treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 2 yearsCalculated using Kaplan-Meier estimation method. Corresponding 95% confidence interval will be provided. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Combination Chemotherapy, DLI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Roger Strair, MD, PhD
Rutgers Cancer Institute of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place