Status:
COMPLETED
Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Stem Cell Transplantation
Leukemia
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
Brief Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, ...
Detailed Description
The Study Drugs: Thiotepa and busulfan are designed to bind to DNA (genetic material of cells), which may cause cancer cells to die. They are commonly used in stem cell transplants. Clofarabine is d...
Eligibility Criteria
Inclusion
- Diagnosed with one of the following diseases:
- Acute myelogenous leukemia (AML) in induction failure, relapse, past first remission, or CR1 considered at risk for relapse
- Myelodysplastic syndromes with International Prognostic Scoring System score (IPSS score) \>/= 2 or myelodysplasia that has not responded to chemotherapy
- Biphenotypic leukemia
- Acute lymphocytic leukemia with induction failure, first complete remission with high risk cytogenetics (e.g. Philadelphia positive chromosome, t(4:11) Remission requiring more than 2 chemotherapy to achieve remission, or any stage beyond CR1
- Chronic Myelogenous Leukemia (CML): second chronic phase, accelerated phase or blast crises with less than 10% blasts in the bone marrow, or CR1 and resistance to Gleevec or other tyrosine kinase inhibitors
- Non-Hodgkin's Lymphoma - induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant)
- Hodgkin's disease - induction failure, second or later complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).
- Chronic Lymphocytic Leukemia that has failed induction therapy or Rai Stages 2-4
- Related or unrelated donor which is HLA-matched or mismatched in 1 HLA A, B, C, DR, or DQ locus is acceptable (i.e. \>/= 9/10 matched related or unrelated donor, matched with molecular high-resolution technique per current std. for BMT program). Cord blood units must match patient at 4, 5, or 6/6 HLA class 1 serological \& II molecular antigens with a min. of 2 x 10e7 TNC/kg recipient weight in the pre-thawed fraction. For patient lacking a matched related or unrelated donor or acceptable cord blood unit(s), a related haploidentical donor (\</= 7/8 allele matched at A, B, C, DR loci) may be used.
- Age \</= 60 years.
- Lansky performance score \>/= 50% for patients \</= 16 years of age, or Zubrod performance status score of 0-2 for patients \> 16 years of age.
- Cardiac function - left ventricular ejection fraction \>/= 40%.
- Pulmonary function - diffusion capacity of at least 50% predicted. Children unable to perform pulmonary function tests (e.g. less than 7 years old) pulse oximetry of \>/= 92% on room air.
- Serum creatinine \< 1.6 mg/dL or creatinine clearance \>/= 50 ml/min.
- SGPT \</= 200 IU/mL, serum bilirubin \< 1.5 x normal.
- Written informed consent and assent as is age appropriate.
- No active infection.
Exclusion
- Pregnancy in women of child bearing potential (pregnancy test performed within 2 weeks of study entry).
- HIV positive (highly immunosuppressive treatment)
- Active CNS leukemia
- Chronic or active Hepatitis B or Hepatitis C. If questions about liver health discuss with PI and strongly consider liver biopsy.
Key Trial Info
Start Date :
March 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00857389
Start Date
March 2 2009
End Date
March 9 2019
Last Update
April 7 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030