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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 - Article


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Adult Hodgkin's Lymphoma


Clinical Trial: 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

This study is no longer recruiting patients.

Sponsored by: Groupe d'Etudes de Lymphomes de L'Adulte
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
Waldenstrom's Macroglobulinemia
recurrent adult Hodgkin's disease
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Drug: interferon alfa
Phase III

MedlinePlus related topics:  Blood and Blood Disorders;   Hodgkin's Disease;   Immune System and Disorders;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Interferon Alfa-2b Following High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: October 1995

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years   -   64 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: See Disease Characteristics; No other concurrent immunotherapy; No concurrent hematopoietic growth factors
  • Chemotherapy: See Disease Characteristics; No concurrent chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: No concurrent radiotherapy
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 to 64
  • Performance status: ECOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminase no greater than 3.0 times upper limit of normal
  • Renal: Creatinine no greater than 1.7 mg/dL
  • Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other prior or concurrent malignancies except curatively treated (by radiotherapy or surgery) basal cell skin cancer or carcinoma in situ

Location Information


France
      Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre-Benite,  69495,  France

United Kingdom, England
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom

Study chairs or principal investigators

Bertrand Coiffier,  Study Chair,  Groupe d'Etudes de Lymphomes de L'Adulte   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067111; GELA-LY302; EU-99008
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003924
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 7, 2008



Page Updated: September 6, 2005
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