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Home > "C" Clinical Trials Conditions > Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML  Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML
Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML
For Condition: Myelodysplastic Syndrome,Chronic Myeloid Leukemia,Acute Myeloid Leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , ILEX Oncology
Synopsis: 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 acute myeloid leukemia (AML), high-grade myelodysplastic syndrome (MDS), or myeloid blast phase of chronic myeloid leukemia (CML) who have relapsed following their initial therapy. The safety of these treatments will also be studied.
Details: Therapeutic options for patients with advanced acute leukemias are limited and the prognosis of these patients is dismal. Hence the need to incorporate new and active drugs into the treatment of these patients. Nucleoside analogs are among the most active anti-leukemic agents. Clofarabine is a novel nucleoside analog with unique metabolic and pharmacokinetic characteristics. Clofarabine has shown to be active in phase I and II studies of patients with relapsed and refractory acute leukemias. This protocol will combine clofarabine with the two currently most powerful antileukemic agents and allow us to proceed to more effective combination therapy.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Age > 18 years. - Must be in first relapse of AML, or must receive treatment as first salvage in primary refractory AML; or have high-risk MDS (> 10% bone marrow blasts) with not more than one prior regimen of chemotherapy (therapy with hematopoietic growth factors, biological or targeted therapies are not counted). Patients in CML myeloid blast phase may receive clofarabine as frontline therapy or in first salvage. - Total bilirubin < 2 mg/dL, SGPT < 4 ULN, creatinine < 2mg/dL. - ECOG performance status < 2. - Cardiac ejection fraction <= 30% (by MUGA scan or echocardiography) - Signed informed consent. - Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized). Exclusion: - Previous treatment with clofarabine - Active, uncontrolled, systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment, or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for study entry. - Symptomatic CNS involvement. - Patients who receive other chemotherapy. Patients must have been off previous therapy for > 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier following discussion with the Principal Investigator.
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
StefanFaderl, Principal Investigator, University of Texas M.D. Anderson Cancer Center
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Stefan Faderl 713-745-4613
Additional Information:
Study ID Numbers: ID03-0181;
Study Start Date: December 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067028
Other Chronic Myeloid Leukemia Studies:
1. Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
2. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
3. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
4. Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients with Acute Myelogenous Leukemia (AML)
5. Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia
Related Studies:
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Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML
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