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Sponsors and Collaborators: |
University of Nebraska SuperGen |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00571662 |
This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplastic Syndromes Multiple Myeloma Non-Hodgkins Lymphoma Hodgkins Disease Peripheral T-Cell Lymphoma |
Drug: Pentostatin Radiation: Total-body irradiation (TBI) Drug: Cyclosporine A (CsA) Drug: Mycophenolate Mofetil (MMF) Drug: G-CSF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Peripheral Blood Stem Cell Transplantation With Minimally Myelosuppressive Regimen of Pentostatin and Low-Dose Total-Body Irradiation |
Estimated Enrollment: | 40 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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Arm I: Experimental |
Drug: Pentostatin
4mg/m2 IV QDx3days (days -10, -9, -8)
Radiation: Total-body irradiation (TBI)
TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.
Drug: Cyclosporine A (CsA)
CsA will be given at 2.0mg/kg IV Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2mg/kg PO BID until day+80, then tapered 10% per week over approximately 3mo. if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD
Drug: Mycophenolate Mofetil (MMF)
MMF 15mg/kg PO BID will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2mo. in absence of GVHD. Doses will be rounded to nearest 250mg.
Drug: G-CSF
10mcg/kg/day subcutaneously for at least 4 consecutive days.
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This is a pilot study which began with a plan to enroll 50 patients (20 related and 30 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients with persistent or progressive malignancy after transplantation will be treated with GM-CSF (cytokine therapy) to assess its toxicity and potential therapeutic efficacy. Patients with persistent or progressive disease who fail or do not qualify for the cytokine therapy portion of the study will become candidates for donor leukocyte infusions.
The purpose of this protocol remains a pilot study which is now regarded as a phase II trial with a plan to enroll 40 ADDITIONAL patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a modified version of the original preparative regimen of Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients who fail will become candidates for donor-leukocyte infusion (DLI).
Primary Objectives
Secondary Objectives
Interventions, evaluation, and follow up will include:
Pentostatin 4 mg/m2/d IV QD x 3 days will be administered with 1000 cc NS hydration before and after pentostatin ten days prior to stem cell infusion (days -10, -9, and -8). Total-body irradiation (TBI): TBI 2.0 Gy will be given on day -1. Antiemetics will be given as needed. Patients will receive one liter normal saline over 2 hours pre TBI. A bone marrow biopsy and aspiration with cytogenetics and flow cytometry will be performed on Day +28, Day +70 and 6, 12, 18 and 24 months following the transplant to monitor hematologic recovery. DNA fingerprinting will also be conducted at the same time at 3, 4, 5, 6, 12, 18, and 24 months to determine chimerism.
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age 19-75 years
Identification of a matched related or unrelated stem cell donor
Diseases:
Acute myelogenous leukemia first complete remission with high-risk cytogenetics>second complete remission minimal residual disease (<10% blasts*). Acute lymphocytic leukemia first complete remission with high-risk cytogenetics >second complete remission minimal residual disease (<10% blasts*). Chronic myelogenous leukemia first chronic phase, accelerated phase (<10% blasts*)blast phase with minimal residual disease (<10% blasts*)second chronic phase. Chronic lymphocytic leukemia recurrence after the front line regimen (related donor transplant), chemorefractory disease (unrelated donor transplant),T-CLL in partial remission or any minimal residual disease. Myelodysplastic syndromes refractory anemia with or without ringed sideroblasts,RAEB, RAEB-T, and CMML (< than 10% blasts*). *both in peripheral blood and bone marrow
Multiple myeloma - after receiving at least one regimen of prior chemotherapy
Non-Hodgkin's Lymphomas:
Small Lympho(plasma)cytic Lymphoma (B-SLL, B-LPL): recurrence after a front line regimen (related donor transplant), or chemorefractory disease (related or unrelated donor transplant). Follicular Low-Grade Lymphoma, Marginal Zone Lymphomas (splenic, nodal, or extranodal/MALT type): chemorefractory disease or > 2 prior regimens. Mantle Cell Lymphoma: first complete or partial remission, refractory disease, or failed prior ASCT. Diffuse Large B-cell Lymphoma, Follicular Large cell Lymphoma, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma: refractory disease, or failed prior ASCT. Burkitt or Acute Lymphoblastic Lymphomas: high-risk disease in remission, chemosensitive persistent or recurrent disease. Cutaneous T-cell Lymphomas: (Mycosis Fungoides, Sezary Syndrome): chemorefractory disease of > 2 prior regimens
Hodgkins Disease: refractory or persistent disease and not candidate for ASCT, or failed prior ASCT.
Peripheral T-cell Lymphoma
Exclusion Criteria:
Significant Organ dysfunction:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
Contact: Rose Solberg, RN | 402-559-4810 | rsolberg@unmc.edu |
United States, Nebraska | |
University of Nebraska Medical Center, Section of Oncology/Hematology | Recruiting |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Gregory Bociek, M.D. | University of Nebraska |
Responsible Party: | University of Neberask Medical Center ( Gregory Bociek, M.D. Principal Investigator ) |
Study ID Numbers: | UNMC-389-00, IRB389-00 |
Study First Received: | December 11, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00571662 |
Health Authority: | United States: Institutional Review Board |
Cyclosporine Chronic myelogenous leukemia Hodgkin lymphoma, adult Miconazole Lymphoma, small cleaved-cell, diffuse Lymphoma, T-Cell, Peripheral Cyclosporins Polymethyl Methacrylate Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Hodgkin Disease Peripheral T-cell lymphoma |
Myelodysplastic syndromes Chronic lymphocytic leukemia Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, B-cell, chronic Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Multiple Myeloma Leukemia, B-Cell Lymphoma, Non-Hodgkin Leukemia, Lymphoid Pentostatin |
Anti-Infective Agents Neoplasms by Histologic Type Disease Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents |