Status:
COMPLETED
A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 ...
Detailed Description
Epoetin alfa is a medication that helps the body make more red blood cells. Researchers want to find out if it will be effective in reducing the need for blood transfusions in patients who have AML or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00656448
Start Date
March 1 2008
End Date
June 1 2013
Last Update
May 30 2018
Active Locations (1)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030