Trial Outcomes & Findings for A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS (NCT NCT00656448)
NCT ID: NCT00656448
Last Updated: 2018-05-30
Results Overview
The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.
COMPLETED
PHASE3
51 participants
12 weeks
2018-05-30
Participant Flow
Recruitment period: March 27, 2008 to February 18, 2010. All recruitment done at the University of Texas (UT) MD Anderson Center.
Of the 51 participants enrolled for the epoetin alfa (Procrit) study, fifty (50) participants were randomized and one excluded as a screening failure.
Participant milestones
| Measure |
Procrit Arm
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
|
No Procrit: Standard Arm
Participants do not receive Procrit before receiving blood transfusions.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Baseline characteristics by cohort
| Measure |
Procrit Arm
n=25 Participants
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
|
No Procruit: Standard Arm
n=25 Participants
Participants do not receive Procrit before receiving blood transfusions.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
62 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group ("Procrit") and standard care group ("No Procrit"). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period.
Outcome measures
| Measure |
Procrit Arm
n=25 Participants
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
|
No Procrit: Standard Arm
n=25 Participants
Participants do not receive Procrit before receiving blood transfusions.
|
|---|---|---|
|
Median Number of Participant Transfusions Required During 12 Weeks of Treatment
|
7 Transfusions per Participant
Interval 1.0 to 16.0
|
7 Transfusions per Participant
Interval 2.0 to 13.0
|
SECONDARY outcome
Timeframe: After 1 course of therapy, one course is 4 weeks.International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.
Outcome measures
| Measure |
Procrit Arm
n=25 Participants
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
|
No Procrit: Standard Arm
n=25 Participants
Participants do not receive Procrit before receiving blood transfusions.
|
|---|---|---|
|
Number of Participants With Complete Remission
Complete Remission
|
24 participants
|
18 participants
|
|
Number of Participants With Complete Remission
Early Death
|
0 participants
|
3 participants
|
|
Number of Participants With Complete Remission
Partial Response
|
1 participants
|
4 participants
|
Adverse Events
Procrit Arm
No Procruit: Standard Arm
Serious adverse events
| Measure |
Procrit Arm
n=25 participants at risk
Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
|
No Procruit: Standard Arm
n=25 participants at risk
Participants do not receive Procrit before receiving blood transfusions.
|
|---|---|---|
|
Nervous system disorders
Posterior reversible encephalopathy
|
4.0%
1/25 • Number of events 1 • Participants followed for one month after removal from study following 12 week treatment period. The overall study period was 5 years and 3 months.
|
0.00%
0/25 • Participants followed for one month after removal from study following 12 week treatment period. The overall study period was 5 years and 3 months.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.0%
1/25 • Number of events 1 • Participants followed for one month after removal from study following 12 week treatment period. The overall study period was 5 years and 3 months.
|
0.00%
0/25 • Participants followed for one month after removal from study following 12 week treatment period. The overall study period was 5 years and 3 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Jorge Cortes M.D./Professor
The University of Texas M. D. Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place