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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Time to treatment failure
  2. Progression-free survival rate
  3. Overall survival rate

Secondary Outcome Measures :
  1. Clinical remission rate
  2. Molecular remission rate

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


  Show 59 Study Locations
Sponsors and Collaborators
Lymphoma Trials Office
Investigators
Study Chair: Andy Haynes, MD Nottingham City Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00006250     History of Changes
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

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