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).
NCT ID: NCT00088218
Last Updated: 2012-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2004-07-31
2008-02-29
Brief Summary
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Detailed Description
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Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. You will also be asked about what medications you are taking currently and about the level of your daily activities. About 2 tablespoons of blood will be collected for routine blood tests and to make sure you are not at increased risk for developing side effects.
Before your first treatment (usually within 14 days), you may have bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. The procedure will be explained to you by your doctor and will require you to sign a separate consent document.
Early study results showed that there is clearly a better response with the combination treatment compared to the clofarabine alone treatment. Because of this, all participants in this study will now be assigned to the clofarabine plus ara-C group. You will receive clofarabine through a vein daily for 5 days in a row. In addition, you will receive injections of ara-C under the skin once a day for 14 days in a row. On those days when both clofarabine and ara-C are taken, the clofarabine will be given approximately 4 hours before the ara-C injections. You can be taught to give the ara-C injections to yourself. Each cycle may be repeated every 3 to 6 weeks. You will be required to record the injections in a medication diary.
Up to 2 of these cycles (for both groups) can be given at this dose schedule. If you show a response to treatment, you can continue with up to 12 cycles of therapy, during which clofarabine will be given for 3 days instead of 5 and ara-C for 7 days instead of 14. Maintenance courses may be given on average every 4 to 7 weeks.
Before every treatment course, you will have a physical exam including measurement of your weight and vital signs. You will also be asked how you are feeling and how you are able to go about your daily routine. At least once a week (more often if your doctor feels it is necessary), you will have blood samples (about 1-2 teaspoons) collected for routine lab tests. Around 3 weeks after your first treatment, you may have samples of bone marrow collected. After that, the bone marrow collections will be performed every 2 weeks (or more often if your doctor feels it is necessary). The bone marrow sample will be tested to evaluate the response of the disease to therapy.
You will need to stay in Houston for the first 4 weeks of treatment. After that, you have to return to Houston to receive the clofarabine treatment, but you can have check-up visits and blood tests with your local doctor. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
After you finished your treatment, and as long you are participating on this study you will be scheduled every 3-6 months to check on the status of the disease and your overall health as long as you stay on the study. Once you are taken off the study, your doctor will decide how often you will have follow-up as part of your standard care.
This is an investigational study. Clofarabine is authorized by the Food and Drug Administration (FDA) for use in research only. Up to 108 participants will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Clofarabine
Clofarabine intravenous (IV) 30 mg/m\^2 daily times 5 days
Clofarabine
1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5)
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.
Clofarabine
1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5)
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).
Interventions
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Clofarabine
1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Stefan Faderl, MD
Role: STUDY_CHAIR
The University of Texas MD Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Faderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008 Sep 1;112(5):1638-45. doi: 10.1182/blood-2007-11-124602. Epub 2008 Jun 18.
Related Links
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M.D. Anderson Cancer Center's website
Other Identifiers
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2004-0183
Identifier Type: -
Identifier Source: org_study_id