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Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on September 11, 2000.   Last Updated on August 6, 2011   History of Changes
Sponsor: Lymphoma Trials Office
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006250
  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 III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Dexamethasone Fludarabine Dexamethasone acetate Mitoxantrone Mitoxantrone hydrochloride Fludarabine monophosphate Doxiproct plus Chlorambucil Dexamethasone Sodium Phosphate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Progression-free survival rate [ Designated as safety issue: No ]
  • Overall survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical remission rate [ Designated as safety issue: No ]
  • Molecular remission rate [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006250

  Show 59 Study Locations
Sponsors and Collaborators
Lymphoma Trials Office
Investigators
Study Chair: Andy Haynes, MD Nottingham City Hospital
  More Information

No publications provided

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: August 6, 2011
Health Authority: United States: Federal Government

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
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Chlorambucil
Fludarabine monophosphate
Fludarabine
Dexamethasone
Mitoxantrone
Dexamethasone acetate
 Dexamethasone 21-phosphate
BB 1101
Vidarabine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012



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