Phase 3
Completed N=50
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Source: ClinicalTrials.gov NCT00656448 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Dec 2013
Primary outcomePrimary: Median Number of Participant Transfusions Required During 12 Weeks of Treatment — 7; 7 Transfusions per Participant
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Number of Participant Transfusions Required During 12 Weeks of Treatment |
7; 7 | — |
| SECONDARY Number of Participants With Complete Remission |
24; 18; 0; 3; 1; 4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00656448). 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. Informational only — not medical advice.