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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genzyme |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00067028 |
Purpose
The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose for these drug combinations are found, the next goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with AML, high-grade MDS, or myeloid blast phase of CML who have relapsed following their initial therapy. The safety of these treatments will also be studied.
| Condition | Intervention | Phase |
|
Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myeloid Leukemia |
Drug: Clofarabine Drug: Idarubicin Drug: Ara-C |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| ChemIDplus related topics: | Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Clofarabine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective Randomized Ph I/II Study of Clofarabine + Ara-C vs Clofarabine + Idarubicin vs Clofarabine + Idarubicin + Ara-C in Patients With 1st Relapse or 1st Salvage of Primary Refractory(AML); and High-Grade (MDS) (>/= 10% Blasts); or With (CML) in Myeloid Blasts Phase as Front Line Therapy or in First Salvage.) |
| Estimated Enrollment: | 136 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Clofarabine + Ara-C
|
Drug: Clofarabine
Clofarabine 40mg/m2 IV over 1h
Drug: Ara-C
Ara-C 1g/m2 IV over 2h
|
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2: Experimental
Clofarabine + Idarubicin
|
Drug: Clofarabine
Clofarabine 40mg/m2 IV over 1h
Drug: Idarubicin
Idarubicin
Drug: Ara-C
Ara-C 1g/m2 IV over 2h
|
|
3: Experimental
Clofarabine + Idarubicin + Ara-C
|
Drug: Clofarabine
Clofarabine 40mg/m2 IV over 1h
Drug: Idarubicin
Idarubicin
Drug: Ara-C
Ara-C 1g/m2 IV over 2h
|
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| Contact: Stefan H Faderl, MD | 713-745-4613 | sfaderl@mdanderson.org |
| United States, Texas | |||||
| M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Contact: Stefan H Faderl, MD 713-745-4613 sfaderl@mdanderson.org | |||||
| Contact: Hagop M Kantarjian, MD 713-792-7026 hkantarj@mdanderson.org | |||||
| M.D. Anderson Cancer Center |
| Genzyme |
| Principal Investigator: | Stefan H Faderl, MD | M.D. Anderson Cancer Center |
More Information
M.D. Anderson Cancer Center's website 
  |
| Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Stefan Faderl M.D./Associate Professor ) |
| Study ID Numbers: | ID03-0181 |
| First Received: | August 8, 2003 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00067028 |
| Health Authority: | United States: Food and Drug Administration |
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