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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)


Phase 3
18 Years
64 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

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)


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma or Hodgkin's disease
Diffuse small cell (i.e., chronic lymphocytic leukemia, small lymphocytic, immunocytoma)
Follicular Mantle cell Peripheral T cell Diffuse large B cell Leukemic (i.e.,
lymphoblastic, Burkitt's) First relapse or first progression after responding to a salvage
regimen and high dose chemotherapy with autologous stem cell transplantation (second
remission) Response of greater than 50% of tumor mass decrease observed at time of
progression Prior high dose chemotherapy plus autologous stem cell transplantation as
first line therapy allowed

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Bertrand Coiffier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Lyon Sud

Authority:

United States: Federal Government

Study ID:

CDR0000067111

NCT ID:

NCT00003924

Start Date:

October 1995

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Waldenström macroglobulinemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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