Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, bortezomib, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
Phase phase 2
Targets CD20, proteasome
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date August 2006
End date January 2011
Trial size 68 participants
Trial identifier NCT00376961, CDR0000494646, S0601, U10CA032102

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
rituximab Rituxan
375 mg/m^2 on day 1 for cycles 1-6.
bortezomib Velcade
1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.
cyclophosphamide
750 mg/m^2 on day 1 of cycles 1-6.
doxorubicin hydrochloride
50 mg/m^2 on day 1 of cycles 1-6.
prednisone
100 mg on days 1-5 of cycles 1-6.
vincristine sulfate
1.4 mg/m^2 on day 1 of cycles 1-6.

Primary Outcomes

Measure
2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
time frame: 0-2 years

Secondary Outcomes

Measure
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).
time frame: At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment
2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
time frame: 0-2 years
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
time frame: Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: - Stage III-IV or bulky stage II disease - Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry: - Cluster of differentiation antigen 19 (CD19) (or CD20) - Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or fluorescent in situ hybridization - Newly diagnosed, previously untreated disease - Bidimensionally measurable disease by conventional techniques - No nonmeasurable disease only - Adequate tumor tissue from original diagnostic specimen available - Tissue obtained by needle aspiration or cytology not allowed - No clinical evidence of central nervous system (CNS) involvement by lymphoma - Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy ≥ grade 2 - No hypersensitivity to bortezomib, boron, or mannitol - No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease free for the past 5 years - HIV negative PRIOR CONCURRENT THERAPY: - No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma - More than 14 days since prior investigational drugs

Additional Information

Official title A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma
Description OBJECTIVES: Primary - Determine the 2-year progression-free survival rate in patients with newly diagnosed mantle cell lymphoma treated with induction therapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib followed by bortezomib maintenance (VM) therapy. Secondary - Determine the response rate (complete, complete unconfirmed, and partial responses) in patients treated with this regimen. - Determine the toxicity of VM in these patients. OUTLINE: This is a multicenter study. - Induction therapy: Patients receive R-CHOP-V induction therapy comprising rituximab IV over ≤ 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin hydrochloride IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1; oral prednisone once daily on days 1-5; and bortezomib IV over 30-90 minutes on days 1 and 4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable disease or better proceed to bortezomib maintenance therapy. - Maintenance therapy: Beginning 3 months after completion of R-CHOP-V induction therapy, patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 months for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 4 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.