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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004904 |
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of treated donor stem cell transplantation in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Small Intestine Cancer |
Biological: anti-thymocyte globulin Biological: filgrastim Drug: cladribine Drug: cyclophosphamide Drug: etoposide Drug: methylprednisolone Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of T Cell Depleted (TCD) Partially Matched Related Donor (PMRD) Hematopoietic Stem Cell Transplantation for High Risk Hematologic Diseases Using Intense Pre and Post Transplant Immunosuppression and Megadose CD34 "Veto" Cells |
Study Start Date: | October 1999 |
OBJECTIVES: I. Determine if megadose CD34 cells and intense immunosuppression administered before and after partially matched related donor (PMRD) hematopoietic stem cell (HSC) transplantation results in engraftment in patients with high risk hematologic malignancies. II. Determine the incidence and severity of acute grade (I-IV) and chronic (limited or extensive) graft versus host disease in patients after rigorous T-cell depletion in PMRD HSC transplantation.
OUTLINE: Harvest: Bone marrow and peripheral blood stem cells (PBSC) are harvested from a related 1, 2, or 3 HLA antigen mismatched donor. PBSC are selected for CD34+ cells and T-cells are depleted. Conditioning: Patients undergo total body irradiation twice daily on days -10 to -7 and once on day
PROJECTED ACCRUAL: A total of 12-20 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | up to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy with relapse after allogeneic bone marrow transplantation (BMT) or autologous BMT if no HLA matched sibling donor is available OR Histologically proven acute myeloid leukemia (AML) without an available HLA matched sibling donor and with one of the following: Failure of induction, defined as inability to obtain remission with 2 courses of induction or failure during treatment Second or greater remission OR Histologically proven acute lymphocytic leukemia (ALL) in an adult over age 15 without an available HLA matched sibling donor and with one of the following: Philadelphia chromosome positivity by cytogenetics or PCR Relapse or second or greater remission Two or more prognostic features (over age 30, WBC on presentation over 35,000/mm3, time to complete response over 4 weeks, t(4:11), or B-cell ALL) OR Histologically proven chronic myelogenous leukemia In chronic phase without an A, B, and DR unrelated matched donor OR In accelerated phase, defined as new cytogenetic abnormalities or difficulty maintaining a normal WBC due to dose limiting cytopenias (thrombocytopenias or anemia) from hydroxyurea or interferon OR In blast transformation OR Histologically proven aplastic anemia without an available HLA matched sibling donor and failure of an immunosuppressive therapy regimen using either cyclosporine, antithymocyte globulin, or both OR Histologically proven lymphoma without an available HLA matched donor and failure of at least 2 different chemotherapy regimens OR Histologically proven cutaneous T-cell lymphoma without an available HLA matched donor and failure of interferon and PUVA (psoralen and ultraviolet A radiation) OR Histologically proven myelodysplastic syndrome without an available HLA matched sibling donor and with one of the following: 5% or greater blasts in marrow Multiple cytogenetic abnormalities History of infections from neutropenia 1, 2, or 3 antigen mismatched related donor available
PATIENT CHARACTERISTICS: Age: Physiologic age 45 and under Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No coronary artery disease requiring medical therapy Resting LVEF at least 40% Pulmonary: FEV1/FVC at least 60% predicted DLCO at least 60% predicted Other: HIV negative No prior malignancy except basal cell or squamous cell skin cancer Other malignancies for which the patient is cured by local surgical therapy, such as head and neck cancer or stage I breast cancer, are considered on an individual basis Not pregnant Negative pregnancy test Fertile patients must use effective contraception No psychiatric illness or mental deficiency that would preclude compliance or informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Richard K. Burt, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067583, NU-97H1, NCI-G00-1691 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004904 History of Changes |
Health Authority: | United States: Federal Government |
monoclonal gammopathy of undetermined significance stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia small intestine lymphoma chronic phase chronic myelogenous leukemia |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia refractory hairy cell leukemia T-cell large granular lymphocyte leukemia acute undifferentiated leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma |
Anti-Inflammatory Agents Blast Crisis Mantle Cell Lymphoma Tacrolimus Ileal Diseases Graft Versus Host Disease Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Thrombocythemia, Hemorrhagic Etoposide Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid |
Glucocorticoids Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Immunologic Factors Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell Leukemia Ileal Neoplasms |
Anti-Inflammatory Agents Cladribine Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Tacrolimus Hormones Ileal Diseases Duodenal Neoplasms Preleukemia Hemorrhagic Disorders Pathologic Processes Neoplasms by Site |
Therapeutic Uses Cardiovascular Diseases Methylprednisolone Hemisuccinate Immunoproliferative Disorders Digestive System Neoplasms Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Glucocorticoids Multiple Myeloma Neoplasms Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Immunologic Factors |