Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003639|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 16, 2004
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: recombinant interferon alfa Drug: chlorambucil Drug: dexamethasone Drug: idarubicin||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||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|
|Study Start Date :||November 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003639
|Royal Victoria Infirmary|
|Newcastle-upon-Tyne, England, United Kingdom, NE1 4LP|
|Study Chair:||Stephen J. Proctor, MD, FRCP, FRCPath||Newcastle-upon-Tyne Hospitals NHS Trust|