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).
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genzyme
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00088218
First received: July 22, 2004
Last updated: August 1, 2012
Last verified: April 2011
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Purpose
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 myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Myelodysplastic Syndrome |
Drug: Clofarabine Drug: Ara-C |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Participants With Response [ Time Frame: Every 2 to 8 weeks ] [ Designated as safety issue: No ]
Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'
Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.
Blood draws once a week until remission then every 2 to 8 weeks during therapy.
| Enrollment: | 95 |
| Study Start Date: | July 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Clofarabine
Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
|
Drug: Clofarabine
1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
Other Names:
|
|
Active Comparator: Clofarabine Plus Ara-C
Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
|
Drug: Clofarabine
1-hour IV infusion 30 mg/m^2 daily times 5 days (Days 1-5)
Other Names:
Drug: Ara-C
20 mg/m^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088218
Locations
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme
Investigators
| Study Chair: | Stefan Faderl, MD | The University of Texas MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00088218 History of Changes |
| Other Study ID Numbers: | 2004-0183 |
| Study First Received: | July 22, 2004 |
| Results First Received: | September 25, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Acute Myeloid Leukemia AML High-Risk Myelodysplastic Syndrome MDS |
Clofarabine Cytarabine ara-C |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Clofarabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013