A Randomized Trial of Procrit vs. No Procrit in AML and High Risk MDS
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Procrit
Intervention description: 40,000 units sq every week starting within two weeks (before or after) from the start of induction chemotherapy.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; AML; Myelodysplastic Syndrome; MDS; Leukemia; Procrit; Epoetin Alfa; Epogen

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.
    

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.