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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00055744 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and methotrexate may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combining cyclosporine with methotrexate in preventing graft-versus-host disease following chemotherapy and allogeneic stem cell transplantation in patients who have refractory or relapsed hematologic cancer, myelodysplastic syndrome, or myeloproliferative disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: filgrastim Biological: rituximab Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: doxorubicin hydrochloride Drug: etoposide Drug: fludarabine phosphate Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation for Refractory or Relapsed Hematologic Malignancies, With Cyclosporine & Methotrexate for Graft-Versus-Host Disease Prophylaxis |
| Study Start Date: | December 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients with persistent or progressive disease after ASCT or mixed chimerism that does not improve after tapering or discontinuing immune suppression may receive donor lymphocyte infusions.
Patients are followed twice weekly for 3 months, monthly for 3 months, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 8-40 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic malignancy of 1 of the following types:
Chronic lymphocytic leukemia, meeting 1 of the following criteria:
Hodgkin's or non-Hodgkin's lymphoma (all types, including mantle cell lymphoma and hepatosplenic gamma/delta T-cell lymphoma) or multiple myeloma, meeting 1 of the following criteria:
Acute myeloid leukemia*, meeting 1 of the following criteria:
Acute lymphoblastic leukemia*, meeting 1 of the following criteria:
OR
Diagnosis of a myelodysplastic syndrome of 1 of the following types:
Diagnosis of a myeloproliferative disorder of 1 of the following types:
Chronic myelogenous leukemia, meeting 1 of the following criteria:
First-degree relative matched donor available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No chronic active hepatitis B
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Daniel Fowler, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000271137, NCI-03-C-0077 |
| Study First Received: | March 6, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00055744 History of Changes |
| Health Authority: | United States: Federal Government |
|
graft versus host disease adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission refractory chronic lymphocytic leukemia recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma |
refractory anemia with excess blasts in transformation refractory anemia with excess blasts chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia chronic myelomonocytic leukemia refractory multiple myeloma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome |
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Anti-Inflammatory Agents Anti-Infective Agents Prednisone Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Cyclosporins Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Abortifacient Agents |
Methotrexate Cardiovascular Diseases Dermatologic Agents Etoposide Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Rituximab Myeloproliferative Disorders Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin |