NCT00513955

Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital Plymouth NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bortezomib may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib to see how well they work compared with combination chemotherapy alone in treating patients with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.

Detailed description

OBJECTIVES: Primary * To evaluate the rates of overall response (complete response \[CR\], CR unconfirmed \[CRu\], and partial response). Secondary * To evaluate the rates of CR and CRu. * To determine the median time to progression. * To determine the median overall survival. * To evaluate the toxicity and tolerability. * To compare the responses to these treatment regimens with those from first line therapy. * To compare the quality of life. OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I (CHOP): Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Arm I has been discontinued April 2012 on recommendation of the DMC. * Arm II (CHOP with bortezomib): Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5. In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment. After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	prednisolone
DRUG	vincristine sulfate
OTHER	questionnaire administration
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2006-06-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2007-08-09
• Last updated: 2014-11-05

Locations

25 sites across 1 country: United Kingdom