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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Recruitment status was: Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Lymphoma | Drug: chlorambucil Drug: dexamethasone Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma |
- Time to treatment failure
- Progression-free survival rate
- Overall survival rate
- Clinical remission rate
- Molecular remission rate
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00006250
Show 59 Study Locations
| Study Chair: | Andy Haynes, MD | Nottingham City Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00006250 History of Changes |
| Other Study ID Numbers: |
CDR0000068182 BNLI-MCD/FMD EU-20035 |
| Study First Received: | September 11, 2000 |
| Last Updated: | September 19, 2013 |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin 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 Analgesics Sensory System Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017