Status:
COMPLETED
Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase I trial is studying the...
Detailed Description
OBJECTIVES: Primary * Determine the toxic effects of adoptive immunotherapy comprising CD8-positive minor histocompatability antigen-specific cytotoxic T-lymphocytes in patients with acute myeloid l...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Undergoing allogeneic hematopoietic stem cell transplantation\* from a major histocompatability complex (MHC)-identical related donor for 1 of the following:
- Primary refractory acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
- AML or ALL beyond first remission
- Therapy-related AML at any stage
- Philadelphia chromosome (bcr-abl)-positive p190-positive ALL at any stage
- Acute leukemia at any stage arising from myelodysplastic syndromes or myeloproliferative disorders, including any of the following:
- Chronic myelomonocytic leukemia
- Chronic myelogenous leukemia
- Polycythemia vera
- Essential thrombocytosis
- Agnogenic myeloid metaplasia with myelofibrosis
- Refractory anemia with excess blasts
- Refractory anemia with excess blasts in transformation NOTE: \*Patients must be enrolled on study prior to undergoing transplantation
- Relapsed disease post-transplantation, as evidenced by 1 of the following criteria:
- Morphologic relapse, as defined by 1 or more of the following:
- Peripheral blasts in the absence of growth factor therapy
- Bone marrow blasts \> 5% of nucleated cells
- Extramedullary chloroma or granulocytic sarcoma
- Flow cytometric relapse, as defined by the appearance of cells with abnormal immunophenotype consistent with leukemia relapse in the peripheral blood or bone marrow (detected before transplantation)
- Cytogenetic relapse, as defined by the appearance in 1 or more metaphases from bone marrow or peripheral blood cells of either a non-constitutional cytogenetic abnormality detected in at least 1 cytogenetic study performed before transplantation OR a new abnormality known to be associated with leukemia
- Molecular relapse, as defined by 1 of the following:
- 1 or more positive polymerase chain reaction (PCR) assays for clonotypic immunoglobulin heavy chain or T-cell receptor gene rearrangement in patients transplanted for B- or T-cell ALL respectively
- 1 or more positive post-transplantation reverse transcription PCR assays for p190 BCR-ABL mRNA fusion transcripts in patients transplanted for Philadelphia chromosome-positive p190-positive ALL
- No grade III or IV acute graft-versus-host disease (GVHD)\*\*
- No extensive chronic GVHD\*\* NOTE: \*\*At time of post-transplant relapse
- PATIENT CHARACTERISTICS:
- Age
- 14 and over (patients \< 14 years of age may be eligible if they are deemed to be of sufficient height and weight by the pediatric attending physician)
- Performance status
- Karnofsky 60-100% (at time of post-transplant relapse)
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No preexisting major nonhematopoietic organ toxicity ≥ grade 3 (at time of post-transplant relapse)
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Concurrent immunosuppressive steroid therapy for GVHD allowed provided both of the following are true:
- Able to taper steroid dose to \< 0.5 mg/kg/day
- No increase of \> 1 grade in acute GVHD OR progression of chronic GVHD within 14 days after dose change
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00107354
Start Date
December 1 1998
Last Update
September 20 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024