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Combination Chemotherapy With or Without Rituximab in Non-Hodgkin's Lymphoma (IDEC-C2B8)

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: NCT00064116
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: CHOP regimen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2001
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 16, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Active Comparator: Arm A: CHOP-21
Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle: day 22 Total number of cycles 6
Drug: CHOP regimen
Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6

Active Comparator: Arm B: CHOP-21 + Rituximab
Rituximab 375 mg/m² i.v. day 1* Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6
Biological: rituximab
Rituximab 375 mg/m² i.v. day 1

Drug: CHOP regimen
Cyclophosphamide 750 mg/m² i.v. day 1 Doxorubicin 50 mg/m² i.v. day 1 Vincristine 2 mg (abs.) i.v. day 1 Prednisone 100 mg/d p.o. days 1 to 5 Recycle day 22 Total number of cycles: 6




Primary Outcome Measures :
  1. Time to treatment failure (TTF) at 3 years [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Complete remission rate after completion of treatment [ Time Frame: 3 years ]
  2. Overall survival at 3 years [ Time Frame: 3 years ]
  3. Tumor control measured by TTF with non-tumor events censored at 3 years [ Time Frame: 3 years ]
  4. Disease-free survival (DFS) measured by TTF after an event during and directly after treatment at 3 years [ Time Frame: 3 years ]
  5. Progression rate determined by dividing the number of patients with disease progression by number of patients with evaluable outcome at 3 years [ Time Frame: 3 years ]
  6. Time to progression measured at 3 years [ Time Frame: 3 years ]
  7. Toxicity assessed by NCI CTC v2.0 after completion of treatment [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00064116


Locations
Show Show 25 study locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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Study Chair: Kevin Imrie, MD Toronto Sunnybrook Regional Cancer Centre
Publications of Results:
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Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00064116    
Other Study ID Numbers: LY9
CAN-NCIC-LY9
ROCHE-CAN-NCIC-LY9 ( Other Identifier: Roche )
MINT-M39045
CDR0000309053 ( Other Identifier: PDQ )
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents