|
Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation Clinical research trials and Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation. Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation clinical trial. Subjects typically recieve the finest healthcare available for their Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation  Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation
Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation
For Condition: childhood chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia
Status: Not yet recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining cellular adoptive immunotherapy with interleukin-2 may be effective treatment for recurrentaccelerated or blast phasechronic myelogenous leukemia. PURPOSE: Phase I/II trial to study the effectiveness of combining cellular adoptive immunotherapy with interleukin-2 in treating patients who have recurrent accelerated or blast phase chronic myelogenous leukemia after undergoing allogeneic stem cell transplantation.
Details: OBJECTIVES: - Determine the safety and potential toxic effects of adoptive immunotherapy comprising CD8+ proteinase 3 (PR3)-specific cytotoxic T-lymphocyte (CTL) clones and interleukin-2 in patients with recurrent accelerated or blastic phase chronic myelogenous leukemia after allogeneic stem cell transplantation. - Determine the in vivo persistence of this therapy and assess migration to bone marrow in these patients. - Determine the antileukemic activity of this therapy in these patients. OUTLINE: This is an open-label, non-randomized, pilot study. Donors undergo leukapheresis for the harvest of allogeneic blood mononuclear cells. CD8+ proteinase 3 (PR3)-specific cytotoxic T-lymphocytes (CTLs) are isolated as clones and generated ex vivo. Patients undergo allogeneic stem cell transplantation. Patients with relapse/progression (more than 5% leukemic blasts in marrow) after transplantation may receive cytoreductive chemotherapy before adoptive immunotherapy. After leukemic relapse or progression, patients receive adoptive immunotherapy comprising allogeneic CD8+ PR3-specific CTLs IV over 1-2 hours on days 0, 7, 14, 28, and 49 and interleukin-2 subcutaneously twice daily on days 28-41 and 49-62. Treatment continues in the absence of unacceptable toxicity. Patients with disease progression or recurrence after adoptive immunotherapy may be eligible to repeat treatment. 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: - Diagnosis of accelerated or blastic phase chronic myelogenous leukemia - Undergoing allogeneic stem cell transplantation - Patient and donor must be HLA-A2 positive - Evidence of proteinase 3 (PR3) expression by immunohistochemistry or flow cytometry - Able and willing to provide blood and bone marrow samples for study - Evidence of recurrent or progressive disease post-transplantation - Morphologic relapse defined as at least 1 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 - Flow cytometric relapse - Cells with abnormal immunophenotype in the peripheral blood or bone marrow by flow cytometry and consistent with leukemia relapse or progression - Cytogenetic relapse or progression - Increase in the number of Philadelphia chromosome-positive metaphases from bone marrow or peripheral blood between 2 consecutive samples after engraftment - Increase in the percentage of bcr/abl+ cells by fluorescence in situ hybridization between 2 consecutive samples after engraftment - Molecular relapse or progression - Polymerase chain reaction assay of bone marrow or peripheral blood mononuclear cells positive for the presence of the bcr/abl mRNA fusion transcript that quantitatively increases by greater than 1 order of magnitude on a subsequent sample - No grade III or IV graft-versus-host disease unresponsive to therapy or requiring treatment with any of the following: - Anti-CD3 monoclonal antibody - Prednisone (or equivalent) more than 0.5 mg/kg/day - Other treatments resulting in the ablation or inactivation of T cells (e.g., anti-T-cell monoclonal antibodies) - No graft rejection or failure PATIENT CHARACTERISTICS: Age - 75 and under Performance status - Karnofsky 40-100% OR - Lansky 40-100% Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Not specified Renal - Not specified Other - No grade 3 or 4 nonhematopoietic organ toxicity - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - No concurrent hydroxyurea Endocrine therapy - See Disease Characteristics - Concurrent immunosuppressive therapy for graft-versus-host disease (GVHD) allowed if 1 of the following: - 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 Other - No concurrent agents that may interfere with function or survival of infused cytotoxic T-lymphocyte clones
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamHo, Study Chair, Fred Hutchinson Cancer Research Center
Additional Information:
Study ID Numbers: CDR0000258557; FHCRC-1671.00
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052598
Other Childhood Chronic Myelogenous Leukemia Studies:
1. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
2. Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation
3. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
4. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
5. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
Related Studies:
Other childhood chronic myelogenous leukemia Clinical Trials
Other Clinical Trials
Other Clinical Trials
Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Recurrent Accelerated or Blast Phase Chronic Myelogenous Leukemia After Undergoing Allogeneic Stem Cell Transplantation
|
|
|
|
|
|
|
|
