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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:
National Cancer Institute (NCI)

September 11, 2000
January 27, 2003
September 20, 2013
May 2000
Not Provided
  • Time to treatment failure
  • Progression-free survival rate
  • Overall survival rate
Not Provided
Complete list of historical versions of study NCT00006250 on ClinicalTrials.gov Archive Site
  • Clinical remission rate
  • Molecular remission rate
Not Provided
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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Drug: chlorambucil
  • Drug: dexamethasone
  • Drug: fludarabine phosphate
  • Drug: mitoxantrone hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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  • 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



  • 18 to 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • No autoimmune hemolytic anemia or active hemolysis
  • Direct Coombs' negative


  • 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


  • Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)


  • No severe cardiac failure
  • Ejection fraction at least 45%


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No concurrent systemic corticosteroids


  • Not specified


  • Not specified


  • No prior therapy
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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Lymphoma Trials Office
Not Provided
Study Chair: Andy Haynes, MD Nottingham City Hospital
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP