Clinical trial · Interventional
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Randomized Study of Procrit vs no Procrit in Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) Undergoing Frontline Myelosuppressive 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 find out if Procrit (epoetin alfa) will help decrease the need for blood transfusions in patients who have Acute Myelogenous Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) and are receiving chemotherapy. Researchers also want to learn about the remission rates (rates of recovery) in patients with cancer who have received treatment with epoetin alfa. The safety and effectiveness of this therapy will also be studied.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Procrit | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Procrit Arm
- description
- 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.
- interventionNames
- Drug: Procrit
- type
- NO_INTERVENTION
- label
- No Procrit: Standard Arm
- description
- Participants do not receive Procrit before receiving blood transfusions.
Primary outcomes (1)
- measure
- Median Number of Participant Transfusions Required During 12 Weeks of Treatment
- timeFrame
- 12 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of AML or high-risk MDS (based on International Prognostic Scoring System (IPSS): refractory anemia with excess of blasts (RAEB) or RAEB in transformation \[RAEB-t\]) receiving frontline induction chemotherapy with any high dose or conventional dose cytarabine-containing regimen or clofarabine-containing regimen at MD Anderson Cancer Center. * Patients must be enrolled on the study within two weeks of the start of induction chemotherapy. * Patients with documented iron, vitamin B12, or folate deficiency are eligible, but should receive replacement therapy while on study. * Understand and voluntarily sign an informed consent form. Exclusion Criteria: * Patients with prior treatment with any form of erythropoietin within the previous month. * Patients with uncontrolled hypertension (\> or =140/90), uncontrolled, clinically significant cardiac arrhythmias, or history of pulmonary embolism or thrombosis within the last 5 years. * New onset (within 3 months prior to randomization) or poorly controlled seizures. * Patients with known hypersensitivity to the active substance or any of the excipients. * Pregnant or lactating women. * Acute Erythroleukemia (M6 French-American-British (FAB) classification) * Hemoglobin greater than or equal to 10g/dl * Patients with head and neck cancer receiving radiation therapy when erythropoiesis-stimulating agents (ESAs) were given to maintain hemoglobin levels of more than 12 g/dL. * Patients with metastatic breast cancer receiving chemotherapy when ESAs were given to maintain hemoglobin levels of more than 12 g/dL. * Patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL. * Patients requiring major surgery would be taken off study due to a higher chance of blood clots being reported while taking ESAs.
References
Publications (0)
Data not yet available