Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell Transplant

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 side effects of cellular adoptive immunotherapy in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after donor stem cell transplant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Treatments: Aldesleukin; Cytarabine; Etoposide; Mitoxantrone

Criteria

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