Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00004179|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 27, 2017
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 chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate||Phase 3|
- Compare the response rate and quality of remission in patients with relapsed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without rituximab.
- Compare the event-free survival and overall survival of patients treated with these regimens.
- Determine the effect of rituximab as maintenance therapy on progression-free survival of these patients.
OUTLINE: This is a randomized, multicenter study.
Induction: Patients are randomized to one of two treatment arms. Patients are stratified according to participating center, prior treatment with purine analogues, age, number of prior induction treatments and best response obtained (complete vs partial remission vs no change/progressive disease), time since diagnosis (less than 2 years vs more than 2 years), and bulky disease (less than 10 cm vs greater than 10 cm).
- Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is administered 1 hour after prednisone and before the IV drugs.
Maintenance: Patients who achieve partial or complete remission are then randomized to one of two treatment arms. Patients are stratified according to rituximab administration during induction (yes vs no), quality of the response (complete vs partial remission vs no change/progressive disease), and participating center.
- Arm I: Patients receive no further therapy.
- Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab IV once every 3 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||475 participants|
|Official Title:||Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||July 19, 2017|
- Response to treatment
- Overall survival [ Time Frame: from randomization ]
- Progression Free survival [ Time Frame: from randomization ]
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): NCT00004179
|Study Chair:||M. H. J. Van Oers, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Study Chair:||Robert Marcus, MD||Cambridge University Hospitals NHS Foundation Trust|
|Study Chair:||Max M. Wolf, MD||Peter MacCallum Cancer Centre, Australia|
|Study Chair:||Richard J. Klasa, MD||British Columbia Cancer Agency|
|Study Chair:||Eva K. Kimby, MD, PhD||Karolinska Institutet|