Status:
COMPLETED
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myel...
Detailed Description
Clofarabine is a chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment of AML and MDS. Altho...
Eligibility Criteria
Inclusion
- Previously untreated AML and high-risk MDS ( \> 10% blasts, or International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
- Age \> 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
- Sign a written informed consent form.
- Adequate liver function (total bilirubin \< 2mg/dL,serum glutamic pyruvic transaminase (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) \< x 4 upper limit of normal (ULN)) and renal function (serum creatinine \< 2mg/dL).
Exclusion
- Patients with \>= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00088218
Start Date
July 1 2004
End Date
February 1 2008
Last Update
August 7 2012
Active Locations (1)
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1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030