Clinical trial · Interventional
Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy
A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Procrit (epoetin alfa) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Procrit
- description
- Starting dose 40,000 units subcutaneously once a week with chemotherapy.
- interventionNames
- Drug: Procrit (epoetin alfa)
- type
- NO_INTERVENTION
- label
- No Procrit
- description
- No intervention.
Primary outcomes (2)
- measure
- Mean Number of RBC Units Transfused During Initial 5 Months of Treatment
- timeFrame
- 5 weeks to 5 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy. 3. Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer. Exclusion Criteria: 1. Hemoglobin greater than or equal to 10 g/dL. 2. Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months. 3. Patients with known hypersensitivity to mammalian-cell derived products or to human albumin. 4. Uncontrolled hypertension 5. History of thrombotic vascular event. 6. Pregnant or lactating women. 7. Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies).
References
Publications (0)
Data not yet available