N/A
N=109
Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01099202 ↗Enrolled (actual)
109
Serious AEs
12.8%
Results posted
Aug 2012
Primary outcome: Primary: Mean Number of RBC Units Transfused During Initial 5 Months of Treatment — 10.63; 13.11 PRBC Units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Procrit (epoetin alfa) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of RBC Units Transfused During Initial 5 Months of Treatment |
10.63; 13.11 | — |
| PRIMARY Number of PRBC Transfusions During Initial 5 Months of Treatment |
6.22; 7.44 | — |
Summary
The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer who have received treatment with epoetin alfa.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of ALL, LL, or Burkitt's receiving induction chemotherapy with Hyper-CVAD, any variant of Hyper-CVAD or augmented BFM at MD Anderson Cancer Center.
- Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy.
- Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer.
Exclusion Criteria
- Hemoglobin greater than or equal to 10 g/dL.
- Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months.
- Patients with known hypersensitivity to mammalian-cell derived products or to human albumin.
- Uncontrolled hypertension
- History of thrombotic vascular event.
- Pregnant or lactating women.
- Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies).
Data sourced from ClinicalTrials.gov (NCT01099202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.