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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

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
recombinant interferon alfa
cyclophosphamide
prednisone
vincristine sulfate
autologous bone marrow transplantation
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academisch Ziekenhuis Utrecht
  • Addenbrooke's NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Lymphoma Trials Office, Stichting Hemato-Oncologie voor Volwassenen Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT00003152
Brief Title
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
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
March 1997 (undefined)
Primary Completion Date
November 1999 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Lymphoma Trials Office, Stichting Hemato-Oncologie voor Volwassenen Nederland

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
469 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Hagenbeek, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Marcus, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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