Status:
TERMINATED
Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes
Lead Sponsor:
Larry Cripe, MD
Collaborating Sponsors:
Celgene Corporation
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter t...
Detailed Description
OUTLINE: This is an open label, multi-center, randomized study. Eligible patients will be randomized to one of two treatment arms: Arm A (Azacitidine + Erythropoietin) * Azacitidine Treatment 50 mg...
Eligibility Criteria
Inclusion
- A bone marrow (BM) aspirate and biopsy that demonstrates MDS with less than 11% blasts.
- Conventional metaphase cytogenetics done within 90 days prior to registration for screening.
- Central pathology review, correlative submission and confirmation of diagnosis is required prior to initiation of therapy (see Study Procedure Manual for details of submission). The FAB and WHO classification of MDS and the IPSS score will be determined at time of central pathology review.
- Correlative marrow aspirate obtained.
- To be eligible for randomization, subjects must have documentation of at least 1 of the following:
- A transfusion dependent anemia (defined by a history of two or more episodes of transfusion within a period of 8 weeks).
- An untransfused hemoglobin \< 10 gm/dl measured on at least two occasions more than 7 days apart in the month prior to randomization.
- Patients must also meet 1 of the following criteria:
- Has not received prior erythropoietin and has a serum erythropoietin level \> 200 IU/L within 14 days of randomization.
- Has received prior erythropoietin without clinical benefit in the judgment of the treating physician.
- Adequate iron status defined as serum ferritin \> 20 ng/ml and transferrin saturation of \> 30% within 90 days prior to randomization.
- Symptoms attributed to the anemia with hemoglobin \< 11 g/dL.
- Folate and Vitamin B12 levels within normal limits within 90 days prior to randomization.
- Life expectancy \> 6 months as judged by the treating investigator.
Exclusion
- No known history of intolerance to erythropoietic agents.
- No prior intensive cytotoxic chemotherapy for a myeloid malignancy including MDS.
- Patients with a history of a non-myeloid malignancy with secondary MDS are eligible for study enrollment provided, in the opinion of the treating investigator and the study chair, the anticipated behavior of the non-myeloid malignancy will not interfere with study participation and evaluation of outcome.
- No known or suspected hypersensitivity to azacitidine or mannitol.
- No hepatic tumors.
- No uncontrolled hypertension (defined as a systolic pressure \> 160 mmHg and/or a diastolic pressure \> 110 mmHg).
- No known hypersensitivity to mammalian cell-derived products or human albumin.
- No history of (within 12 months) deep venous thrombosis (DVT), pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion.
- No history of (within 6 months) cerebrovascular accident (\[CVA\] includes ischemic, embolic and hemorrhagic), transient ischemic attack (TIA), myocardial ischemia (includes Unstable Angina, Q wave Myocardial Infarction \[QwMI\] and non-Q wave Myocardial Infarction \[NQMI\], or other arterial thrombosis.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 4-week period thereafter.
- Females with childbearing potential must have a negative pregnancy test within 7 days prior to being randomized. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00379912
Start Date
September 1 2006
End Date
December 1 2008
Last Update
February 14 2018
Active Locations (9)
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1
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
2
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
3
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
4
Arnett Cancer Care
Lafayette, Indiana, United States, 47904