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Trial: NCT00003215 [RDF]

Label NCT00003215
Slug nct00003215
Trialid NCT00003215
Lookup name NCT00003215
Provenance http://clinicaltrials.gov/show/NCT00003215?displayxml=true
Lastchanged date May 14, 2012
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003215
Overall status Completed
Id info secondary id SWS-SAKK-38/97
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 400
Number of arms
Is section 801
Is fda regulated No
Brief title Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma
Acronym
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)
Study type Interventional
Id info nct alias
Completion date March 2004
Verification date May 2012
Why stopped
Id info org study id SAKK 38/97
Required header url https://clinicaltrials.gov/show/NCT00003215
Study design Allocation: Randomized, Primary Purpose: Treatment
Source Swiss Group for Clinical Cancer Research
Primary completion date March 2004
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 3
Start date April 1997
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: - Compare the efficacy of sequential high-dose chemotherapy and autologous peripheral blood stem cell transplantation with standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed aggressive non-Hodgkin's lymphoma and poor prognostic factors. - Compare the toxic effects of these 2 regimens in these patients. - Compare the response rates and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive standard chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients receive cyclophosphamide IV over 30 minutes, doxorubicin IV, and vincristine IV on day 1. Patients receive oral prednisone daily on days 1-5. Treatment repeats every 21 days for 6-8 courses. Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-60 days after initiation of the last course of CHOP. - Arm II: Patients receive 5 regimens of chemotherapy administered in sequence. - Regimen A : Patients receive CHOP as in Arm I. - Regimen B: Three weeks after starting regimen A, patients receive high-dose cyclophosphamide IV over 24 hours on day 1. Patients without initial bone marrow involvement receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until autologous peripheral blood stem cells (PBSC) are harvested. PBSC are harvested on days 13-15 or when blood counts recover. Patients with initial bone marrow involvement do not undergo harvest of PBSC at this time, but receive G-CSF SC daily. - Regimen C: Two to three weeks after high-dose cyclophosphamide, patients receive vincristine IV and high-dose methotrexate IV over 6 hours on day 2. Patients receive leucovorin calcium IV every 6 hours on days 3-5 beginning 24 hours after initiation of the methotrexate infusion. - Regimen D: Within 1-2 weeks after the administration of methotrexate in regimen C, patients receive methylprednisolone IV followed 6 hours later by high-dose etoposide IV over 10 hours on day 1. Patients receive methylprednisolone IV on day 2. Patients without initial bone marrow involvement receive G-CSF SC daily beginning on day 3 and continuing until blood counts recover. Patients with initial bone marrow involvement receive G-CSF SC daily until autologous PBSC are harvested. PBSC are harvested on days 10-14 or when blood counts recover. - Regimen E: Myeloablative therapy and autologous PBSC transplantation begin 16-40 days after the administration of etoposide. Patients receive mitoxantrone IV over 1 hour every 2 hours for 3 doses on day 2 and melphalan IV over 30 minutes on day 5. PBSC are reinfused on day 6 beginning at least 24 hours after the administration of melphalan. Patients receive G-CSF SC or by continuous infusion beginning on day 7. Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-100 days after PBSC transplantation. Patients at high risk of developing CNS disease receive prophylactic intrathecal chemotherapy. Patients may receive cytarabine, methotrexate, and hydrocortisone or methotrexate and hydrocortisone every 1-2 weeks for 6 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 4-5 years.
Condition browse 4f4629fc4452a844c4b1ec783f3ae84f
Intervention browse 5d3d5fd0249528b8b05a97b163d0bb30
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group a37face3b16e4608f1801045a0aa891b
Oversight info Switzerland: Swissmedic (Oversight_info)
Eligibility a1f71661b70f9346ed5e7ea0b06090ad
Keywords Anaplastic Large Cell Lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma
Conditions Lymphoma
Locations 13d88f8784f5f3cb5db396c5100a3f50, 21f4fa697397b7b6ead5dfb7401e24b4, 41906fcf14568c0517ed8f73362ee2e3, 68660e3c7f54dd02efce61b5a56dd7e5, 7531addb6b488ccbc4cfbb723797f5be, 77b1d0302d705d5488789a0e2b70574a, 7b850cd6dfada3a432c6cea99a0f6afd, 80875da5e5915ffb96ad90e03b16ce39, 8b3d5a45b44e434bc2a6b6a0206a2018, abca0bfccdd6c5a7c0739fd89ff8a4e0, d1242fcfca5f863d3be556ddc9113fd4, d4fee23063b1e07d338d4fd5bd9bf218
Links None
Results references PMID:16888080
Arm groups None
Location countries Austria, Germany, Greece, Italy, Switzerland
Interventions leucovorin calcium (Intervention), melphalan (Intervention), cyclophosphamide (Intervention), bone marrow ablation with stem cell support (Intervention), cytarabine (Intervention), doxorubicin hydrochloride (Intervention), radiation therapy (Intervention), CHOP regimen (Intervention), prednisone (Intervention), peripheral blood stem cell transplantation (Intervention), vincristine sulfate (Intervention), methylprednisolone (Intervention), filgrastim (Intervention), therapeutic hydrocortisone (Intervention), mitoxantrone hydrochloride (Intervention), methotrexate (Intervention), etoposide (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials 2a64074c499ac6d242cc37fc1ab76fe6