A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
- To evaluate the rates of overall response (complete response [CR], CR unconfirmed
[CRu], and partial response).
- 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
- 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 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
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Simon Rule, MD
United Kingdom: Medicines and Healthcare Products Regulatory Agency