Status:
UNKNOWN
Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnorm...
Detailed Description
OBJECTIVES: Primary * Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic st...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of any of the following hematological cancers with a poor prognosis:
- Acute myeloid leukemia meeting 1 of the following criteria:
- Third complete remission (CR3) or beyond
- CR2 after an early bone marrow relapse (\< 24 months)
- Refractory disease after ≥ 2 chemotherapy courses of induction therapy
- Acute lymphoblastic leukemia meeting 1 of the following criteria:
- CR3 after ≥ 1 bone marrow relapse
- CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy)
- Chronic myelogenous leukemia meeting the following criteria:
- Accelerated phase
- Second chronic phase
- No other treatment options
- Multiple myeloma meeting the following criteria:
- Failed conventional therapy (including autologous hematopoietic stem cell transplantation)
- No other treatment alternatives
- Chronic lymphocytic leukemia meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Non-Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Not eligible for standard myeloablative allograft due to increased toxicity
- Healthy related donor available and meeting the following criteria:
- Brother, sister, father, mother, cousin, uncle, or aunt
- At least an identical HLA haplotype
- Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR)
- Different on ≤ 4 alleles on the other haplotype
- No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No contraindication to allogeneic transplantation, including any of the following:
- Cardiac systolic ejection fraction \< 40%
- DLCO level limiting use of fludarabine
- Creatinine clearance \< 30 mL/min
- Transaminases and/or bilirubin \> 3 times upper limit of normal (unless due to Gilbert disease or cancer)
- HIV seropositivity
- Human T-cell lymphotrophic virus type 1 seropositivity
- Uncontrolled bacterial, viral, or fungal infection
- No contraindication to any of the study drugs
- No prior or concurrent psychiatric illness
- No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
- No concurrent serious, uncontrolled condition
- No patients deprived of liberty or subject to legal protection
- PRIOR CONCURRENT THERAPY:
- No participation in a study of allografts in the past month
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00740467
Start Date
January 1 2008
Last Update
January 28 2010
Active Locations (1)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273