Chemotherapy Plus Interferon Alfa Alone or With Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Follicular Non-Hodgkin's Lymphoma. A Prospective, Randomized, Phase III Clinical Trial.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by interferon alfa alone or combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkin's lymphoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the progression free and overall survival, toxicity, and mortality of marrow ablative chemo/radiotherapy in addition to peripheral blood stem cell transplantation and interferon alfa maintenance therapy versus interferon alfa maintenance therapy alone in patients with follicular non-Hodgkin's lymphoma.

OUTLINE: This is a randomized study. All patients receive 8 courses of cyclophosphamide/vincristine/prednisone (CVP) chemotherapy. Cyclophosphamide and vincristine IV are given on day 1, along with oral prednisone on days 1-5. Courses are repeated every 3 weeks. Patients are randomized to receive one of two treatments 4 weeks after completion of CVP chemotherapy if a partial or complete response is achieved and there are less than 15% monoclonal B-lymphocytes in the bone marrow. Patients randomized to arm I receive interferon alfa subcutaneously 3 times per week for a maximum of 3 years. Patients randomized to arm II receive cyclophosphamide IV followed by subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF). Leukapheresis begins after leukocyte, platelet, and CD34+ levels recover and lasts 3-4 hours on 2-3 consecutive days. If an insufficient number of stem cells are collected from the peripheral blood, bone marrow harvesting is performed. After stem cell collection, a conditioning regimen consisting of cyclophosphamide IV on days -4 and -3 and total body irradiation on day -1 is administered. Stem cells are infused on day 0. If granulocyte and platelet counts recover within 8 weeks, patients receive interferon alfa maintenance therapy as in arm I. Patients are followed every 4 months until death.

PROJECTED ACCRUAL: A total of 469 patients will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Anticipated)

469

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Previously untreated follicular stage III or IV non-Hodgkin's lymphoma At least one measurable mass

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL) Renal: Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL) Cardiovascular: No severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%) Neurologic: No neurologic disease Pulmonary: No pulmonary disease Other: Not pregnant No prior malignancies except nonmelanoma skin cancer or carcinoma in situ of the cervix Not HIV positive No psychiatric or metabolic disease

PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunotherapeutic drugs, chemotherapy, or radiotherapy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Stichting Hemato-Oncologie voor Volwassenen Nederland
Lymphoma Trials Office

Investigators

  • Study Chair: Robert Marcus, MD, Cambridge University Hospitals NHS Foundation Trust
  • Study Chair: Anton Hagenbeek, MD, PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

November 1, 1999

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-20963
  • BNLI-EORTC-20963
  • HOVON-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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