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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003215 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells.
It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: filgrastim Drug: CHOP regimen Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: melphalan Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
At least two of the following risk factors:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Austria | |
Allgemeines Krankenhaus der Stadt Wien | |
Vienna, Austria, A-1090 | |
Germany | |
Dr. Horst-Schmidt-Kliniken | |
Wiesbaden, Germany, D-65199 | |
Greece | |
Saint Savvas Cancer Hospital of Athens | |
Athens, Greece, 11522 | |
Italy | |
European Institute of Oncology | |
Milano, Italy, 20141 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, 1011 | |
Hopital Cantonal Universitaire de Geneve | |
Collonge-Bellerive, Switzerland, CH-1245 | |
Universitatsspital-Basel | |
Basel, Switzerland, CH-4031 | |
Kantonsspital - St. Gallen | |
St. Gallen, Switzerland, CH-9007 | |
Klinik Hirslanden | |
Zurich, Switzerland, CH-8008 | |
Oncology Institute of Southern Switzerland | |
Bellinzona, Switzerland, CH-6500 | |
Ratisches Kantons und Regionalspital | |
Chur, Switzerland, CH-7000 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 |
Study Chair: | Daniel C. Betticher, MD | University Hospital Inselspital, Berne |
Study ID Numbers: | CDR0000066075, SWS-SAKK-38/97, EU-97037 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003215 History of Changes |
Health Authority: | United States: Federal Government |
stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma |
stage IV adult immunoblastic large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma anaplastic large cell lymphoma |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Lymphoma, Large-Cell, Anaplastic Methotrexate Aggression Etoposide Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Vincristine Glucocorticoids Doxorubicin Folic Acid Hydrocortisone acetate Mitoxantrone Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Melphalan Immunologic Factors Folate Leucovorin |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Hydrocortisone acetate Mitoxantrone Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites |