Status:
COMPLETED
Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the don...
Detailed Description
OBJECTIVES: * Determine the feasibility and efficacy of a reduced-intensity conditioning regimen comprising alemtuzumab, fludarabine, melphalan, and thiotepa followed by allogeneic peripheral blood s...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Chronic myelogenous leukemia
- Accelerated phase or blast phase
- Acute myeloid leukemia, meeting any of the following criteria:
- In second or subsequent remission
- In primary induction failure
- In partial remission
- In resistant relapse
- Chronic lymphocytic leukemia
- In Richter's transformation
- High-grade non-Hodgkin's lymphoma
- Refractory to standard treatment
- Myeloproliferative disorders
- Undergoing transformation to terminal stages
- Myelodysplastic syndromes (MDS), including any of the following:
- Refractory anemia with excess blasts
- Transformation to acute leukemia
- MDS secondary to chemotherapy
- Partially-matched related family donor available
- One HLA haplotype match
- No HLA-matched (10/10 or 9/10) sibling donor or unrelated donor available NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- PATIENT CHARACTERISTICS:
- Age
- 18 to 55
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- SGOT and SGPT \< 3 times upper limit of normal (ULN)
- No active or persistent viral hepatitis
- Renal
- Creatinine \< 2.0 mg/dL\* OR
- Creatinine clearance \> 60 mL/min\* NOTE: \*Unless due to malignancy
- Cardiovascular
- LVEF ≥ 45%
- Pulmonary
- DLCO ≥ 60% of predicted\* (corrected for hemoglobin) NOTE: \*Unless patient is given clearance by a pulmonary consultation
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 2 years after completion of study treatment
- HIV negative
- Human T cell lymphotrophic virus type 1 negative
- No serious co-morbid medical condition
- No other medical condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00104975
Start Date
February 1 2005
End Date
May 1 2008
Last Update
December 15 2016
Active Locations (1)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028