Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

September 16, 2013 updated by: Scotland and Newcastle Lymphoma Group

Randomised Controlled Trial of CID (Chlorambucil, Idarubicin, Dexamethasone) Versus CD (Chlorambucil, Dexamethasone) for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma (Kiel Classification) Followed by Randomised Controlled Assessment of Standard Dose Interferon Versus Low Dose Interferon Versus No Further Therapy as Maintenance Treatment After Remission Induction

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 and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the remission induction rates and toxicity of chlorambucil plus dexamethasone with or without idarubicin in patients with stage II-IV low grade non-Hodgkin's lymphoma. II. Assess the additional value of a period of consolidation/maintenance treatment utilizing low dose interferon alfa or standard dose interferon alfa versus no further treatment in relationship to the duration of event-free survival in these patients.

OUTLINE: This is a randomized, open label, controlled, multicenter study. Patients are randomized into one of two arms for induction chemotherapy. Arm I: Patients receive oral chlorambucil three times daily for 3 consecutive days, oral idarubicin daily for 3 consecutive days, and oral dexamethasone twice daily for 5 consecutive days every 21 days. Arm II: Patients receive oral chlorambucil three times daily for 3 consecutive days and oral dexamethasone twice daily for 5 consecutive days every 21 days. Treatment for both arms continues for up to 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses of chemotherapy, patients are reassessed. If they have achieved maximal complete response or good partial response, patients are randomized into one of three arms. Arm I: Patients receive no further treatment until disease progresses. Arm II: Patients receive low dose interferon alfa subcutaneously three times per week for a maximum of 3 years in the absence of disease progression. Arm III: Patients receive standard dose interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of disease progression. Patients are followed every 8-12 weeks for 3 years.

PROJECTED ACCRUAL: There will be 200 patients accrued into this study with approximately 150 patients entering the second phase of this study.

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • United Kingdom
    • England
      • Newcastle-upon-Tyne, England, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary

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

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed B cell low grade non-Hodgkin's lymphoma Stage II, III or IV Measurable disease No chronic lymphatic leukemia, prolymphocytic leukemia and hairy cell leukemia, angioimmunoblastic lymphadenopathy, mycosis fungoides, Sezary's syndrome and T-zone lymphoma, plasmacytoma, T cell lymphomas, or centroblastic lymphoma No CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.96 mg/dL AST/ALT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.65 mg/dL OR Creatinine clearance no greater than 40 mL/min Cardiovascular: No history of myocardial infarction in the past 12 months No severe or uncontrolled cardiac failure Other: No history of malignant disease except basal cell carcinoma or carcinoma in situ of the cervix No active peptic ulceration, significant dyspepsia, or history of hematemesis or melena No concurrent medical or psychological condition that may preclude study participation Not pregnant Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy for any malignant disease Prior radiotherapy for localized disease that subsequently relapses permitted Surgery: Not specified

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
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

Scotland and Newcastle Lymphoma Group

Investigators

  • Study Chair: Stephen J. Proctor, MD, FRCP, FRCPath, Newcastle-upon-Tyne Hospitals NHS Trust

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

November 1, 1993

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 15, 2004

First Posted (Estimate)

July 16, 2004

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066724
  • SNLG-NHL-VIII
  • EU-98034

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Lymphoma

Clinical Trials on recombinant interferon alfa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe