Mantle Cell Lymphoma Trials

Bortezomib Study

Description:
A parallel randomised phase 2 trial of CHOP chemotherapy with or without Bortezomib in relapsed mantle cell lymphoma.

Phase:
Phase II

Start:
01/04/2007

End:
30/08/2014

7 Years

Locations:
This trial has been closed earlier than anticipated. The reason for this is that it has become very difficult to recruit to - many MCL patient now recieve either VCHOP or RCHOP as first line treatment for MCL. This means that fewer and fewer patients are

Background:
Mantle cell lymphoma has the worst prognosis of all sub-types of Non-Hodgkin's lymphomas, with a 5 year survival rate of around 27%. Many patients will respond to first line treatment, but this response is rarely complete and the patients are likely to relapse within 18 months. At this point further treatment is often inadequate. This study has been investigating the response of patients to CHOP chemotherapy with or without Bortezomib in the relapsed setting. Single agent Bortezomib has previously demonstrated a 33% overall response rate when given to 133 patients with relapsed mantle cell lymphoma. A complete remission rate 8% of the patients in this trial was noticed, with a median duration of response of 9.2 months. The combination of CHOP with Bortezomib proposed in this trial is novel. In the last couple of years, practice has changed and physicians now prefer not to prescribe CHOP chemotherapy alone. In response to this, the trial has been modified. Now all patients enrolled into the trial will receive Bortezomib

Treatments:
This study is no longer randomised. All registered patients receive a sub cutaneous injection of Bortezomib (Velcade) on day one and on day eight in addition to CHOP Chemotherapy in 6 -8 cycles

Objectives:
The primary objective is to evaluate the rates of overall response (CR, Cru and PR).
Secondary objectives are to evaluate the rates of complete response, to determine the median time to progression, to determine the median overall survival, to evaluate the toxicity and tolerability of the two treatments, to compare the responses with the response of the first line therapy, and to compare the quality of life with the two treatments.

Methods:
A trial patient information sheet and any local information on relapsed mantle cell lymphoma will be given to eligible patients once relapse is confirmed.

Patients offering informed consent will be randomised via the remote system set up for this trial. Patients will be randomised to receive either CHOP chemotherapy alone or in combination with Bortezomib. CHOP will be given as the standard 21 day cycle. Bortezomib will be given on days 1 and 8 of this 21 day cycle. A maximum of 8 cycles will be given, with restaging after 4 cycles and upon completion of trial treatment. Patients will be followed for progression and overall survival.

Enrollment Criteria:

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Plymouth Hospitals NHS Trust UKCRC Plymouth University Peninsula

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