Trial Outcomes & Findings for Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy (NCT NCT01099202)

Results Overview

Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

5 weeks to 5 Months

Results posted on

2012-08-27

Participant Flow

Recruitment Period 3/11/2003 - 5/25/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Procrit Starting dose 40,000 Units subcutaneously once a week with chemotherapy.	No Procrit No intervention.
Overall Study STARTED	55	54
Overall Study COMPLETED	55	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Procrit n=55 Participants Starting dose 40,000 Units subcutaneously once a week with chemotherapy.	No Procrit n=54 Participants No intervention.	Total n=109 Participants Total of all reporting groups
Age Continuous	39 years n=93 Participants	42 years n=4 Participants	41 years n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	30 Participants n=4 Participants	52 Participants n=27 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	24 Participants n=4 Participants	57 Participants n=27 Participants
Region of Enrollment United States	55 participants n=93 Participants	54 participants n=4 Participants	109 participants n=27 Participants

PRIMARY outcome

Timeframe: 5 weeks to 5 Months

Population: Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.

Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.

Outcome measures

Outcome measures
Measure	Procrit n=41 Participants Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.	No Procrit n=38 Participants No intervention.
Mean Number of RBC Units Transfused During Initial 5 Months of Treatment	10.63 PRBC Units Standard Deviation 6.29	13.11 PRBC Units Standard Deviation 5.18

PRIMARY outcome

Timeframe: 5 weeks to 5 Months

Population: Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.

Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.

Outcome measures

Outcome measures
Measure	Procrit n=41 Participants Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.	No Procrit n=38 Participants No intervention.
Number of PRBC Transfusions During Initial 5 Months of Treatment	6.22 transfusions Standard Deviation 3.87	7.44 transfusions Standard Deviation 3.28

Adverse Events

Procrit

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

No Procrit

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Procrit n=55 participants at risk Starting dose 40,000 Units subcutaneously once a week with chemotherapy.	No Procrit n=54 participants at risk No intervention.
Cardiac disorders Deep Vein Thrombosis	5.5% 3/55 • Number of events 3 • 8 years, 2 months	3.7% 2/54 • Number of events 2 • 8 years, 2 months
Infections and infestations Infection	9.1% 5/55 • Number of events 5 • 8 years, 2 months	3.7% 2/54 • Number of events 2 • 8 years, 2 months
Nervous system disorders Seizures	1.8% 1/55 • Number of events 1 • 8 years, 2 months	3.7% 2/54 • Number of events 2 • 8 years, 2 months
Cardiac disorders Pulmonary Embolism	1.8% 1/55 • Number of events 1 • 8 years, 2 months	0.00% 0/54 • 8 years, 2 months
Cardiac disorders Stroke	1.8% 1/55 • Number of events 1 • 8 years, 2 months	0.00% 0/54 • 8 years, 2 months
General disorders Death	0.00% 0/55 • 8 years, 2 months	1.9% 1/54 • Number of events 1 • 8 years, 2 months
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.8% 1/55 • Number of events 1 • 8 years, 2 months	0.00% 0/54 • 8 years, 2 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

Phone: 713/794-5783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place