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Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Clinical research trials and Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation  Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
For Condition: childhood acute lymphoblastic leukemia,adult acute lymphoblastic leukemia,secondary acute myeloid leukemia,adult acute myeloid leukemia,childhood acute myeloid leukemia and other myeloid malignancies
Status: Not yet recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies work in different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells in patients undergoing donor stem cell transplantation. PURPOSE: Phase I/II trial to study the effectiveness of biological therapy in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the safety and potential toxic effects of adoptive immunotherapy comprising CD8-positive Wilms' tumor (WT1) gene-specific cytotoxic T-lymphocyte (CTL) clones and interleukin-2 in patients with HLA-A2 or HLA-A24-positive advanced acute myeloid leukemia or acute lymphoblastic leukemia at high risk for relapse after allogeneic stem cell transplantation. - Determine the in vivo persistence of this therapy and assess migration to the bone marrow in these patients. - Determine the anti-leukemic effects of this therapy in these patients. OUTLINE: Donors undergo leukapheresis or peripheral blood draw for stem cell harvest to generate CD8-positive Wilms' tumor (WT1) gene-specific cytotoxic T-lymphocyte (CTL) clones before allogeneic stem cell transplantation. After post-transplantation hematopoietic recovery, patients receive treatment for either highest-risk disease (prophylactically) or relapsed disease. - Highest-risk disease group: Patients receive CD8-positive Wilms' tumor (WT1) gene-specific CTL clones IV over 1-2 hours on days 0, 7, 14, 28, and 49. Patients receive interleukin-2 subcutaneously twice daily on days 28-41 and 49-62 in the absence of unacceptable toxicity. - Relapsed-disease group: Some patients with morphologic evidence of leukemic relapse may receive standard salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive Wilms' tumor (WT1) gene-specific CTL clones and interleukin-2 as in the highest-risk group. Patients in both groups who have progressive disease after study may be eligible for retreatment with CD8-positive Wilms' tumor (WT1) gene-specific CTL clones. Patients are followed until day 90, at day 180, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within 3-5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Planned allogeneic stem cell transplantation for one of the following diagnoses: - Primary refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) - AML or ALL beyond first remission - Therapy-related AML at any stage - Philadelphia chromosome-positive ALL at any stage - Acute leukemia at any stage arising from myelodysplastic or myeloproliferative syndromes, including: - Chronic myelomonocytic leukemia - Chronic myelogenous leukemia - Polycythemia vera - Essential thrombocytosis - Agnogenic myeloid metaplasia with myelofibrosis - Patient and donor must be HLA-A2 or HLA-A24 positive - Evidence of Wilms' tumor (WT1) gene overexpression by polymerase chain reaction (PCR) - No grade III or IV graft-versus-host disease unresponsive to therapy or requiring therapy with any of the following: - Prednisone - Anti-CD3 monoclonal antibody - Other treatments resulting in T-cell inactivation or ablation - No graft rejection or failure - Highest-risk disease group: More than 5% blasts detected in bone marrow or peripheral blood just prior to or at time of transplantation - One of the following types of relapsed disease after transplantation: - Morphologic relapse defined by one or more of the following: - Peripheral blasts in absence of growth factor therapy - Bone marrow blasts more than 5% of nucleated cells - Extramedullary chloroma or granulocytic sarcoma - Cells with abnormal immunophenotype and consistent with leukemia relapse in the peripheral blood or bone marrow detected by flow cytometry - Cytogenetic relapse defined as the appearance in 1 or more metaphases from peripheral blood or bone marrow of either a non-constitutional cytogenetic abnormality identified in at least 1 cytogenetic study performed before transplantation or a new abnormality known to be associated with leukemia - Molecular relapse defined as one of the following: - 1 or more positive PCR assays for clonotypic immunoglobulin heavy chain (IgH) gene rearrangement for patients with B-cell ALL - 1 or more positive PCR assays for T-cell receptor (TCR) gene rearrangement for patients with T-cell ALL - 1 or more positive post-transplantation reverse transcription PCR assays for bcr-abl mRNA fusion transcripts in patients with bcr-abl-positive ALL PATIENT CHARACTERISTICS: Age - 75 and under Performance status - Karnofsky 40-100% OR - Lansky 40-100% Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute neutrophil count greater than 500/mm^3 for at least 7 days prior to study (highest-risk group) Hepatic - Not specified Renal - Not specified Other - Not pregnant - Fertile patients must use effective contraception - No pre-existing nonhematopoietic organ toxicity greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - Concurrent immunosuppressive therapy for graft-versus-host disease (GVHD) allowed if meets 1 of the following criteria: - Not receiving corticosteroids - Corticosteroid dose can be tapered no more than 0.5 mg/kg/day without an increase to grade III or IV acute GVHD or progression of chronic GVHD within 14 days of dose change Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamHo, Study Chair, Fred Hutchinson Cancer Research Center
Additional Information:
Study ID Numbers: CDR0000258507; FHCRC-1655.00
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052520
Other Secondary Acute Myeloid Leukemia Studies:
1. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
3. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
4. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
5. Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
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Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
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