Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00006250 |
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: chlorambucil Drug: dexamethasone Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride | Phase 3 |
OBJECTIVES:
- Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.
- Compare the efficacy and tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score [low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)]. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.
- Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.
Treatment continues every 4 weeks for 4-8 courses.
Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse.
PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma |
Study Start Date : | May 2000 |
- Time to treatment failure
- Progression-free survival rate
- Overall survival rate
- Clinical remission rate
- Molecular remission rate

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma
- REAL classification grade I, II, or III
-
Treatment necessity indicated by presence of the following:
- B symptoms
- Bone marrow failure
- Bulky or progressive disease
- Compression syndromes
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- No autoimmune hemolytic anemia or active hemolysis
- Direct Coombs' negative
Hepatic:
- Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)*
- Bilirubin no greater than 2.5 times ULN* NOTE: *Unless attributable to lymphoma
Renal:
- Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)
Cardiovascular:
- No severe cardiac failure
- Ejection fraction at least 45%
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months after study
- HIV negative
- No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer
- No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent systemic corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior therapy

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): NCT00006250

Study Chair: | Andy Haynes, MD | Nottingham City Hospital |
ClinicalTrials.gov Identifier: | NCT00006250 |
Other Study ID Numbers: |
CDR0000068182 BNLI-MCD/FMD EU-20035 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 20, 2013 |
Last Verified: | March 2007 |
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 |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Fludarabine Fludarabine phosphate Mitoxantrone Chlorambucil Anti-Inflammatory Agents Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Analgesics Sensory System Agents |