Study of Stem Cell Transplant for Leukemia and Myelodysplastic Syndromes Using Clofarabine and Busulfan Regimen
Completed · Phase 2
Conditions studied: Leukemia, Myelodysplastic Syndrome
In brief
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
Key facts
- Study ID
- NCT00852163
- Run by
- Baylor Research Institute
- People needed
- 20
- Starts
- 2007-03-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2013-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 Inclusion Criteria:
- 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.
You may not qualify if…
- 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
Where it is running
- Baylor University Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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