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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003196 |
Purpose
RATIONALE: Peripheral stem cell transplantation with donor white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation with donor white blood cells in treating older patients with hematologic cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: filgrastim Drug: cyclosporine Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Induction of Mixed Hematopoietic Chimerism In Older Patients With B-Cell Malignancies and in Selected Other Patients, Using Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion: A Pilot Study. |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 1997 |
OBJECTIVES: I. Determine whether mixed hematopoietic chimerism can be safely established using a nonmyeloablative conditioning regimen in patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma.
II. Determine whether mixed chimerism can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes.
OUTLINE: Patients with advanced malignancies receive cytoreduction per FHCRC-506 to reduce tumor bulk. Patients may also receive radiation to high risk bulky disease or skeleton lesions before transplantation. Donors receive subcutaneous filgrastim (G-CSF) on days -4 to 0. Peripheral blood stem cells (PBSC) are collected on days -1 and 0. Patients receive cyclosporine IV on days -1 and 0, then orally on days 1-35. On day 0, patients undergo total body irradiation, then receive unmodified G-CSF mobilized PBSC by infusion. Mycophenolate mofetil is administered beginning after the PBSC infusion and continuing until day 27. Patients are evaluated for lymphoid and myeloid chimerism on days 28 and 56. Patients with mixed chimerism on day 56, and with no evidence of graft-versus-host disease (GVHD) receive the first infusion of donor lymphocytes (DLI) on day 65. Up to 3 more infusions may be administered, if there is evidence of increasing or persistent cancer, provided no active GVHD or low blood counts are present. Donors undergo leukopheresis and collection of nonmobilized peripheral bone marrow cells (PBMC) on the day of the first DLI. The unirradiated donor PBMC are administered to the patient by IV infusion over 30 minutes. Patients are followed weekly until day 90 after the last DLI, then at 4 and 6 months, then every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20 patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma will be accrued for this study in 2 years. A maximum of 10 patients with other hematologic malignancies will also be accrued.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Age 50 to 75 years: Not eligible for autologous transplantation OR Failed prior autologous transplantation Non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) Failed prior therapy with alkylating agent and/or fludarabine Multiple myeloma Stage II or III disease Received prior chemotherapy Under 50 years considered on case by case basis: NHL, CLL, or multiple myeloma at high risk of regimen related toxicity Under 75 years with other hematologic malignancies: Treatable by allogeneic bone marrow transplant High risk for regimen related toxicity using standard dose regimens Autografting contraindicated Myelodysplastic syndromes Myeloproliferative syndromes Acute leukemia in remission Chronic myelogenous leukemia in second chronic phase Hodgkin's disease No rapidly progressive, high grade NHL HLA genotypically identical sibling donor No CNS involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 50 to 75 Performance status: Karnofsky 50-100% (>70% if older than 65) Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT less than 4 times ULN Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac failure requiring therapy Cardiac ejection fraction at least 40% No poorly controlled hypertension Pulmonary: No severe defects in pulmonary function testing No supplementary continuous oxygen Other: Not pregnant Fertile patients must use adequate contraception during and for 12 months after therapy Donor Characteristics: 12 to 75 years HLA genotypically identical sibling Not identical twin Adequate veins for leukopheresis or agree to central venous catheter Not pregnant HIV negative No allergy to filgrastim (G-CSF) No current serious systemic illness
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000066032, FHCRC-1225.00, NCI-G98-1374 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003196 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma Waldenstrom macroglobulinemia stage II multiple myeloma stage III multiple myeloma stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission |
polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia B-cell chronic lymphocytic leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent mantle cell lymphoma recurrent marginal zone lymphoma |
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Polycythemia Anti-Infective Agents Cyclosporine Lymphoma, Mantle-Cell Mycophenolic Acid Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis |
Thrombocythemia, Hemorrhagic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Waldenstrom Macroglobulinemia B-cell Lymphomas Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |
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Anti-Infective Agents Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Mycophenolic Acid Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Cyclosporins Leukemia Preleukemia |
Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Mycophenolate mofetil Cardiovascular Diseases Dermatologic Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes |
