Trial Outcomes & Findings for CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease (NCT NCT04526288)
NCT ID: NCT04526288
Last Updated: 2024-05-23
Results Overview
The survival (in days) of subjects in the two arms will be compared using the log-rank test.
TERMINATED
PHASE2
1 participants
Up to 730 days post-randomization.
2024-05-23
Participant Flow
Patients arrived to Fred Hutchinson Cancer Center, Transplant Clinic, for transplant screening and disease staging. Upon confirmation of ability to proceed to transplant and concurrent enrollment in transplant protocol, recruitment to this study was offered. The dates of the study's recruitment period were 3/16/2021-12/07/2022.
Participant milestones
| Measure |
Arm A (alloHCT)
Patients undergo allogeneic transplant (alloHCT) and do not receive investigational product.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
|
Arm B (CPX-351, alloHCT)
Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A (alloHCT)
Patients undergo allogeneic transplant (alloHCT) and do not receive investigational product.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
|
Arm B (CPX-351, alloHCT)
Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease
Baseline characteristics by cohort
| Measure |
Arm A (alloHCT)
n=1 Participants
Patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
|
Arm B (CPX-351, alloHCT)
Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 730 days post-randomization.Population: We did not enroll sufficiently to allow for analysis.
The survival (in days) of subjects in the two arms will be compared using the log-rank test.
Outcome measures
| Measure |
Arm A (alloHCT)
n=1 Participants
Patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
|
Arm B (CPX-351, alloHCT)
Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|
|
Overall Survival
|
730 Days
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: From the time of randomization up to 2 years post-randomization. For descriptive purposes, we shall also report survival and relapse-free survival from time of transplant up to 2 years post-transplant among patients who receive a transplant.Population: Data was not collected for this outcome measure.
The following comparisons will be made: (1) number of days elapsing between the date of minimal residual disease (MRD) identification and the date of death or relapse, (2) among transplanted patients, the number of days elapsing between the date of transplantation and the date of death or relapse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years post-randomizationPopulation: Data was not collected for this outcome measure because the one participant did not start transplantation conditioning.
This outcome will be assessed among patients who have begun transplantation conditioning 60 days and 180 days following enrollment will be compared using the chi-squared test. The time to transplantation among the two arms will be compared by comparing the number of days elapsed between enrollment and the initiation of transplantation conditions by the log-rank test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years post-randomizationPopulation: The one participant enrolled did not proceed with transplant on the study.
Among the patients receiving transplantation, the proportion of patients in each arm receiving myeloablative transplantation conditioning will be compared using the chi-squared or Fisher's exact test. Among patients receiving transplantation, the proportion of patients in each arm receiving donor stem cells from a haploidentical donor, an unrelated donor, or from cord blood unit will each be compared using the chi-squared or Fisher's exact test.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (alloHCT)
Arm B (CPX-351, alloHCT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Filippo Milano, Director of FHCC Cord Blood Transplant Program
Fred Hutchinson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place