Status:
COMPLETED
Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan Regimen
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Clofarabine in combination with Busulfan is effective as a preparative transplant regimen for the treatment of leukemia and myelodysplastic syndromes
Detailed Description
The success of allogeneic hematopoietic transplantation in the treatment of myeloid malignancies is determined by two main factors: the limiting of regimen-related toxicity and the prevention of recur...
Eligibility Criteria
Inclusion
- Disease Criteria:
- Acute myelogenous leukemia (AML)
- Acute lymphocytic leukemia (ALL)
- Myelodysplastic syndromes (MDS) Refractory anemia (RA) with adverse cytogenetics (SWOG criteria) or beyond (RAEB, RAEB-T, AML)
- Other Myeloproliferative Disorders Myelofibrosis, Agnogenic Myeloid Metaplasia, Chronic Myelomonocytic Leukemia (CMML)
- Chronic lymphocytic leukemia (CLL) High risk or advanced disease
- Other
- 18 years of age or older
- Related or unrelated donor with HLA criteria as follows:
- Related donors: a serologic equivalent HLA Class I (A, B, and C) and Class II DRB1 or DQB1 matched donor OR a donor who is a single 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci
- Unrelated donors: sequence-based typing fully matched A, B, C, DRB1, and DQB1 allele-matched donor OR a donor who is no greater than 1 antigen mismatched for A, B, C, DRB1, or DQB1 loci
- Able to provide valid informed consent.
- Female patients must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- Male and female patients must use an effective contraceptive method during the study and for up to 12 months after study treatment.
Exclusion
- Organ Function Criteria:
- Cardiac: symptomatic coronary artery disease or ejection fraction \<45% or uncontrolled cardiac failure
- Pulmonary: FEV1 or DLCO (corrected) \<50% of predicted values and/or receiving continuous supplementary oxygen
- Hepatic: Bilirubin ≥ 1.2 mg/dL or AST/ALT ≥ 3x upper limit of normal (ULN) unless the liver is involved with malignant disease
- Renal: creatinine clearance \< 60 mL/min (24-hour urine collection) or \<50 mL/min (Glofil test)
- Karnofsky score \<60%
- Active CNS disease
- Prior hematopoietic transplantation (autologous or allogeneic) \<6 months prior to study entry
- Use of investigational agents less than or equal to 30 days before study entry.
- Life threatening, or clinically significant infection
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- Female patients who are pregnant or breast feeding
- HIV-positive
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00852163
Start Date
March 1 2007
End Date
December 1 2011
Last Update
April 4 2013
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246