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T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies Clinical research trials and T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies clinical trial. Subjects frequently obtain the most expert healthcare possible for their T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies  T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
For Condition: plasma cell neoplasm,chronic myeloproliferative disorders,Leukemia,myelodysplastic and myeloproliferative diseases,Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells from a donor are rejected by the body’s normal cells. Eliminating the T cells from the donor cells before transplanting them, infusing donor T cells that have been treated in the laboratory, and giving cyclosporine may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of T-cell-depleted allogeneic stem cell transplantation followed by laboratory-treated donor T cells after immunoablativeinduction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients who have hematologic malignancies (cancer of the blood or bone marrow).
Details: OBJECTIVES: Primary - Determine engraftment in patients with hematologic malignancies treated with T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning. - Determine the safety and feasibility of administering in vitro cultured donor Th2/Tc2 cells with T-cell-depleted allogeneic peripheral blood stem cells from haploidentical-related donors to these patients. Secondary - Correlate donor Th2/Tc2 cell dose with graft rejection/failure, acute graft-versus-host disease (GVHD), and nonrelapse mortality (within 100 days after transplantation) in these patients. - Correlate levels of host immunosuppression before transplantation conditioning, as evaluated by peripheral blood CD4 counts, with graft rejection/failure within 100 days after transplantation and the level of donor hematopoietic chimerism 28 days after transplantation in these patients. - Correlate donor-versus-recipient natural killer cell alloreactivity with graft rejection/failure, acute GVHD, and relapse of malignant disease in patients treated with this regimen. - Determine the development of allospecific cytotoxic T-lymphocytes after transplantation in patients with myeloid or lymphoid leukemia. - Correlate serum interleukin-7 and interleukin-15 levels with in vivo changes in host lymphocyte subpopulations in these patients during sequential immunoablative chemotherapy, before allogeneic stem cell transplantation, and during immune reconstitution after transplantation. OUTLINE: This is a pilot, dose-escalation study of donor Th2/Tc2 cells. - Patients receive 1 of 2 induction chemotherapy regimens according to diagnosis. - Regimen A (Hodgkin's lymphoma, non-Hodgkin's lymphoma [except lymphoblastic lymphoma], chronic lymphocytic leukemia, prolymphocytic leukemia, or multiple myeloma): Patients receive rituximab IV (if they have CD20+ B-cell malignancies) on day 1; fludarabine IV over 30 minutes on days 1-4; etoposide, doxorubicin, and vincristine IV continuously on days 1-4; cyclophosphamide IV over 30 minutes on day 5; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover. - Regimen B (lymphoblastic lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, refractory anemia with excess blasts, myeloproliferative disorders, chronic myelomonocytic leukemia, or chronic myelogenous leukemia): Patients receive G-CSF SC beginning 24 hours before initiating induction chemotherapy and continuing until blood counts recover. Patients also receive fludarabine IV over 30 minutes and cytarabine IV over 4 hours on days 1-5. For both regimens, treatment repeats every 21 days for 1-3 courses. Patients who achieve remission or who have responsive or stable disease after induction chemotherapy then proceed to transplantation preparative regimen chemotherapy. - Transplantation preparative regimen chemotherapy: Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours twice daily beginning on day -1 and continuing IV or orally until day 100. Patients with no acute GVHD at day 100 taper cyclosporine over 12 weeks. - Allogeneic stem cell transplantation (SCT): Patients undergo T-cell-depleted allogeneic peripheral blood SCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. - Patients receive donor Th2/Tc2 cells IV on day 0 after SCT. Cohorts of 6-10 patients receive escalating doses of donor Th2/Tc2 cells until feasibility is determined. (The first cohort does not receive donor cells). Feasibility is defined as the dose level at which no more than 3 of 6 or 5 of 10 patients die or experience grade III or IV acute GVHD by day 100 post-transplantation. - Donor lymphocyte infusion (DLI): Patients with persistent or progressive malignant disease after transplantation or mixed chimerism that does not improve after tapering or discontinuing immunosuppression therapy may receive DLI. DLI may be administered alone or in combination with chemotherapy. DLI repeats every 4 weeks until adequate donor chimerism is achieved or until GVHD develops. Patients are followed at 28 and 100 days and then at 6, 9, 12, 18, and 24 months. PROJECTED ACCRUAL: A total of 6-40 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following hematologic malignancies: - Acute myeloid leukemia (AML), meeting 1 of the following criteria: - In first complete remission (CR1), meeting 1 of the following criteria: - Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following: - Complex karyotype [ 3 abnormalities] - inv(3) or t(3;3) - t(6;9) - t(6;11) - Monosomy 7 - Trisomy 8, alone or with an abnormality other than t(8;21), t(9;11), inv(16), or t(16;16) - t(11;19) (q23;p13.1) - Failed to achieve CR after primary induction chemotherapy - Secondary AML - In second or subsequent remission (CR2 or greater) - Acute lymphoblastic leukemia, meeting 1 of the following criteria: - In CR1, meeting 1 of the following criteria: - Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following: - Translocations involving 11q23, t(9;22), or bcr-abl rearrangement - Failed to achieve CR after primary induction chemotherapy - In CR2, if CR1 was < 12 months - In CR3 or greater - Myelodysplastic syndromes (MDS) - INT-2 or high-risk by International Prognostic Scoring System - No MDS with Fanconi anemia - Chronic myelogenous leukemia (CML), meeting 1 of the following criteria: - Accelerated phase with treatment failure after imatinib mesylate - Blast phase - Myeloproliferative disorders, meeting 1 of the following criteria: - Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria: - Hemoglobin < 10 g/dL - WBC < 4,000/mm^3 OR > 30,000/mm^3 - Abnormal cytogenetics, including +8, 12p- - Polycythemia vera or essential thrombocythemia in transformation to secondary AML - Myelodysplastic/myeloproliferative disease - Chronic myelomonocytic leukemia - Hodgkin's lymphoma or non-Hodgkin's lymphoma - Refractory lymphoma with progressive disease during combination chemotherapy - Relapse after OR ineligible for autologous stem cell transplantation (SCT) - Chronic lymphocytic leukemia - Treatment failure* after fludarabine, chlorambucil, and at least 1 other salvage regimen - Prolymphocytic leukemia (PLL), meeting 1 of the following criteria: - T-PLL - Treatment failure* after alemtuzumab and at least 1 other regimen - B-PLL - Treatment failure* after fludarabine and at least 1 other salvage regimen - Multiple myeloma, meeting 1 of the following criteria: - Relapse after autologous SCT - Plasma cell leukemia - Adverse cytogenetics, defined as 1 of the following: - del(13q) - 11q translocation NOTE: *Treatment failure is defined as relapse within 6 months OR failure to achieve remission - Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses: - Primary or secondary leukemia - Refractory anemia with excess blasts - CML - Other eligible diagnosis in transformation to acute leukemia - Expected survival of approximately 1 year or less with conventional therapy - No active CNS involvement by malignancy* - Prior CNS involvement with no current evidence of CNS malignancy allowed NOTE: *Active CNS malignancy is defined by lymphoma: tumor mass on CT scan or leptomeningeal disease OR leukemia: blasts present on cerebrospinal fluid cytospin - Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR) - Recipient and donor must have at least a 2-antigen disparity in either the host-versus-graft or graft-versus-host direction - Parent or offspring donor who is mismatched for a single HLA antigen (i.e., 5/6 HLA) is allowed - No sibling donor who is 6/6 HLA-matched OR mismatched for a single HLA antigen (i.e., 5/6 HLA) - No unrelated donor identified in a prior or current National Marrow Donor Program registry search PATIENT CHARACTERISTICS: Age - 18 to 40 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - At least 3 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count 1,000/mm^3* - Platelet count 20,0000/mm^3* (without transfusion) NOTE: *Lower values may be accepted at the discretion of the principal investigator or study chairperson if due to bone marrow involvement by malignancy Hepatic - ALT and AST 2.5 times upper limit of normal (ULN)* - Bilirubin 2.5 times ULN* - Unconjugated hyperbilirubinemia consistent with Gilbert's syndrome allowed - No chronic active hepatitis B infection - Hepatitis B core antibody positive allowed provided patient is surface antigen negative and has no evidence of active infection - No hepatitis C viral infection - Seronegative for anti-hepatitis C immunoglobulin (Ig) G or IgM NOTE: *Higher levels may be accepted at the discretion of the principle investigator or study chairperson if such elevations are due to liver involvement by malignancy Renal - Creatinine 1.5 mg/dL OR - Creatinine clearance 50 mL/min Cardiovascular - LVEF 45% Pulmonary - DLCO 50% of expected value (corrected for blood hemoglobin level and alveolar volume) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - HIV negative - No active infection not responding to antimicrobial therapy - No psychiatric disorder that would preclude study compliance or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - At least 2 weeks since prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Recovered from all prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDean, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000357432; NCI-04-C-0116
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080925
Other Chronic Myeloproliferative Disorders Studies:
1. The Collection of Peripheral Blood Lymphocytes and Marrow Progenitor Cells from Normal Volunteers and Volunteers with Lymphoid or Hematologic Malignancies
2. Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
3. Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
4. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
5. Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer
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T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
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