Interferon Alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003924|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 20, 2004
Last Update Posted : August 7, 2013
RATIONALE: Interferon-alfa may interfere with the growth of cancer cells. Giving interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an effective treatment for Hodgkin's disease or non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa-2b following chemotherapy and stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: recombinant interferon alfa||Phase 3|
OBJECTIVES: I. Determine the efficacy of interferon alfa-2b in reducing the relapse rate in patients with recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma in second remission following high dose chemotherapy and autologous stem cell transplantation. II. Compare the time to disease progression and survival in this patient population treated with interferon alfa-2b vs no further treatment. III. Assess the tolerability of these treatment regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymphoma subtype. Patients are randomized to one of two treatment arms. Arm I: Patients receive no further therapy following high dose chemotherapy and autologous stem cell transplantation. Arm II: Beginning 4 weeks after high dose chemotherapy and autologous stem cell transplantation, patients receive interferon alfa-2b subcutaneously three times a week. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4-5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Official Title:||A European Randomized Multicenter Study of Interferon Alfa-2b Versus No Treatment After Intensive Therapy and Autologous Hematopoietic Stem Cell Transplantation for Relapsing Lymphoma Patients (Non-Hodgkin Lymphomas and Hodgkin's Disease)|
|Study Start Date :||October 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003924
|Hopital Jules Courmont - Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Christie Hospital N.H.S. Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Bertrand Coiffier, MD||Centre Hospitalier Lyon Sud|