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Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

This study has been completed.

Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00064116
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: bleomycin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: prednisolone
Drug: prednisone
Drug: rituximab
Drug: vincristine sulfate
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Etoposide    Methotrexate    Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Mitoxantrone hydrochloride    Mitoxantrone    Prednisone    Vincristine sulfate    Vincristine    Rituximab    Tositumomab    Etoposide phosphate    Bleomycin    Bleomycin sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control
Official Title:   Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)

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

Primary Outcome Measures:
  • Time to treatment failure (TTF) at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete remission rate after completion of treatment [ Designated as safety issue: No ]
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Tumor control measured by TTF with non-tumor events censored at 3 years [ Designated as safety issue: No ]
  • Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years [ Designated as safety issue: No ]
  • Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years [ Designated as safety issue: No ]
  • Time to progression measured at 3 years [ Designated as safety issue: No ]
  • Toxicity assessed by NCI CTC v2.0 after completion of treatment [ Designated as safety issue: Yes ]

Study Start Date:   May 2001

Detailed Description:

OBJECTIVES:

  • Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab.
  • Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens.
  • Compare the disease-free and overall survival rate of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:

    • CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    • MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:

    • CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1.
    • CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1.
    • PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy.
    • MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification

    • Diagnosed within the past 6 weeks
    • CD20+ disease
    • Ann Arbor stage II, III, or IV disease or stage I bulky disease
  • International Prognostic Index (IPI) score of 0 or 1

    • Score 0 defined by all of the following:

      • Stage I or II disease
      • ECOG performance status of 0 or 1
      • Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN)
    • Score 1 defined by 1 of the following:

      • Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN
      • Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN
      • Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN
  • Previously untreated disease
  • Mediastinal B-cell lymphoma allowed
  • No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
  • No transformed lymphoma
  • No primary CNS lymphoma
  • No primary gastrointestinal (MALT) lymphoma
  • No post-transplant lymphoproliferative disorder

PATIENT CHARACTERISTICS:

Age

  • 18 to 60

Performance status

  • See Disease Characteristics
  • ECOG 0-3

Life expectancy

  • At least 3 months

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 2.0 mg/dL*
  • Transaminases no greater than 3 times normal*
  • No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma

Renal

  • Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No uncompensated heart failure
  • No dilatative cardiomyopathy
  • No coronary heart disease with ST segment depression on ECG
  • No severe uncompensated hypertension

Pulmonary

  • No chronic lung disease with hypoxemia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known allergic reactions against foreign proteins
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No concurrent disease that would preclude study treatment
  • No active infections requiring systemic antibiotics or antiviral medications
  • No severe uncompensated diabetes mellitus
  • No clinical signs of cerebral dysfunction
  • No severe psychiatric disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior murine antibodies

Chemotherapy

  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy

Surgery

  • Not specified

Other

  • No prior lymphoma-specific treatment
  • More than 12 weeks since prior participation in another clinical trial
  • No prior participation in this study
  • No other concurrent study medication
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064116

Locations
Canada, Alberta
Cross Cancer Institute at University of Alberta    
      Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary    
      Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
Saint John Regional Hospital    
      Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation    
      St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre    
      Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital    
      Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre at Grand River Hospital    
      Kitchner, Ontario, Canada, N2G 1G3
London Regional Cancer Program at London Health Sciences Centre    
      London, Ontario, Canada, N6A 465
Northeastern Ontario Regional Cancer Centre    
      Sudbury, Ontario, Canada, P3E 5J1
Ottawa Hospital Regional Cancer Centre - General Campus    
      Ottawa, Ontario, Canada, K1H 8L6
St. Catharines General Hospital at Niagara Health System    
      St. Catharines, Ontario, Canada, L2R 5K3
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre    
      Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre - Mississauga Site    
      Mississauga, Ontario, Canada, L5B 1B8
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal    
      Montreal, Quebec, Canada, H2L 4MI
Hopital Charles Lemoyne    
      Greenfield Park, Quebec, Canada, J4V 2H1
Hopital du Saint-Sacrement, Quebec    
      Quebec City, Quebec, Canada, G1S 4L8

Sponsors and Collaborators
National Cancer Institute of Canada

Investigators
Study Chair:     Kevin Imrie, MD     Edmond Odette Cancer Centre at Sunnybrook    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000309053, CAN-NCIC-LY9, ROCHE-CAN-NCIC-LY9, MINT-M39045
First Received:   July 8, 2003
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00064116
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult diffuse large cell lymphoma  
contiguous stage II adult diffuse large cell lymphoma  
noncontiguous stage II adult diffuse large cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage IV adult diffuse large cell lymphoma  

Study placed in the following topic categories:
Prednisone
Methylprednisolone
Lymphoma, small cleaved-cell, diffuse
Prednisolone acetate
Cyclophosphamide
Etoposide phosphate
Lymphoma, large-cell
Lymphoma, B-Cell
Methotrexate
Lymphoma
Etoposide
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Methylprednisolone acetate
Vincristine
Bleomycin
Doxorubicin
Folic Acid
Lymphatic Diseases
Antibodies
B-cell lymphomas
Prednisolone
Mitoxantrone
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Sensory System Agents
Therapeutic Uses
Abortifacient Agents
Analgesics
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2008




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