Status:
COMPLETED
Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
Up to 54 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's im...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of clofarabine when administered with melphalan and thiotepa followed by allogeneic stem cell transplantation in patients with high-risk an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of 1 of the following:
- Acute myelogenous leukemia, meeting 1 of the following criteria:
- In first complete remission (CR), meeting 1 of the following criteria:
- Poor risk \[no t(15,17), inv 16, or t(8,21)\]
- Not a candidate for total body irradiation (TBI)
- Any infant in first CR
- In second CR, meeting the following criteria:
- All patients
- In more than second CR OR relapsed/refractory disease, meeting the following criteria:
- All patients
- Blast percentage \> 5% and \< 25% in bone marrow (BM) at the time of stem cell transplantation (SCT)
- Acute lymphoblastic leukemia, meeting 1 of the following criteria:
- In first CR, meeting 1 of the following criteria:
- Poor risk \[t(9;22), t(4;11) AND no CR after 7-28 days of induction\]
- Not a candidate for TBI
- Any infant in first CR
- In second CR, meeting the following criteria:
- All patients
- In more than second CR OR relapsed/refractory disease, meeting the following criteria:
- All patients
- Blast percentage \> 5% and \< 25% in BM at the time of SCT
- Acute undifferentiated or biphenotypic leukemia, meeting the following criteria:
- All patients
- Blast percentage \> 5% and \< 25% in BM at the time of SCT
- Chronic myelogenous leukemia, meeting the following criteria:
- All patients
- In first chronic phase
- Myelodysplastic syndrome, meeting 1 of the following criteria:
- Primary high risk disease
- Stage \> RAEB1
- Secondary high risk disease
- All patients
- Any stage
- Juvenile myelomonocytic leukemia
- All patients
- No doubling of peripheral blast counts within a period of 2 weeks
- No active CNS disease
- HLA-compatible donor available meeting 1 of the following criteria:
- Related donor
- Genotypically or phenotypically matched at ≥ 7 or 8 of HLA-A, -B, -C and -DRB1 alleles
- Unrelated donor meeting 1 of the following criteria:
- 8 of 8 alleles matched
- For patients \< 18 years old only: 7 or 8 alleles matched with the mismatch at only 1 HLA-A, -B, -C, or -DRB1 allele
- Two HLA-compatible unrelated cord blood (UCB) units available meeting the following criteria:
- HLA-matched minimally at 4 of 6 HLA-A, HLA-B, and DRB1 allele
- HLA-A and HLA-B matched at intermediate resolution by molecular technique
- DRB1 allele matched at high resolution by molecular technique
- Both matched UCB units with cryopreserved nucleated cell dose ≥ 1.5 x 10\^7/kg
- PATIENT CHARACTERISTICS:
- Karnofsky OR Lansky performance status 70-100%
- SGOT \< 2 times upper limit of normal
- Bilirubin \< 1.5 mg/dL (unless there is liver disease involvement)
- Creatinine normal OR creatinine clearance \> 60 mL/min
- LVEF \> 50% at rest OR shortening fraction ≥ 29%
- Patients with asymptomatic pulmonary disease with no prior risk factors OR symptomatic pulmonary disease with diffusion capacity \> 50% of predicted (corrected for hemoglobin) are eligible
- No active uncontrolled viral, bacterial, or fungal infection
- No known HIV I or II positivity
- No known human T-cell lymphotrophic virus I or II positivity
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No hydroxyurea within the past 2 weeks
- No allogeneic or autologous stem cell transplantation within the past 6 months
Exclusion
Key Trial Info
Start Date :
November 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00423514
Start Date
November 20 2006
End Date
June 18 2021
Last Update
December 27 2022
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065