Suspended

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)

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What is being tested

recombinant interferon alfa

Biological
Who is being recruted

Blood Protein Disorders+38

+ Cardiovascular Diseases

+ Chronic Disease

From 18 to 64 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 1995
See protocol details

Summary

Principal SponsorLymphoma Study Association
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00003924
Principal SponsorLymphoma Study Association
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

360 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesNeoplasms, Plasma CellBurkitt LymphomaHodgkin DiseaseLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-Lymphoma

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, FranceOpen Hopital Jules Courmont - Centre Hospitalier Lyon Sud in Google Maps

Christie Hospital N.H.S. Trust

Manchester, United Kingdom
Suspended2 Study Centers