Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
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.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma|
- Disease progression [ Designated as safety issue: No ]
- Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||June 2014|
- 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 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 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.
|Basingstoke and North Hampshire NHS Foundation Trust||Recruiting|
|Basingstoke, England, United Kingdom, RG24 9NA|
|Contact: Contact Person 44-125-631-3282 firstname.lastname@example.org|
|Good Hope Hospital||Recruiting|
|Birmingham, England, United Kingdom, B75 7RR|
|Contact: Matthew A. Lumley, MD 44-121-378-6206 email@example.com|
|Birmingham Heartlands Hospital||Recruiting|
|Birmingham, England, United Kingdom, B9 5SS|
|Contact: Guy Pratt, MD, MRCP, MRCPath 44-121-424-3698|
|Blackpool Victoria Hospital||Recruiting|
|Blackpool, England, United Kingdom, FY3 8NR|
|Contact: Contact Person 44-123-330-3760 firstname.lastname@example.org|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Contact Person 44-122-324-5151 email@example.com|
|Darent Valley Hospital||Recruiting|
|Dartford, England, United Kingdom, DA2 8DA|
|Contact: Contact Person 44-1322-428-508 firstname.lastname@example.org|
|Harrogate District Hospital||Recruiting|
|Harrogate, England, United Kingdom, HG2 7SX|
|Contact: Claire Hall, MD 44-11-3206-5570|
|Leeds General Infirmary||Recruiting|
|Leeds, England, United Kingdom, LS1 3EX|
|Contact: Roderick Johnson, MD 44-113-392-3766|
|Royal Liverpool University Hospital||Recruiting|
|Liverpool, England, United Kingdom, L7 8XP|
|Contact: Contact Person 44-151-706-4344 email@example.com|
|London, England, United Kingdom, SE1 9RT|
|Contact: Contact Person 44-207-188-1421 firstname.lastname@example.org|
|Mid Kent Oncology Centre at Maidstone Hospital||Recruiting|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Contact: Contact Person 44-162-222-5041 email@example.com|
|Royal Victoria Infirmary||Recruiting|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Contact: Contact Person 44-191-282-9408 firstname.lastname@example.org|
|James Paget Hospital||Recruiting|
|Norfolk, England, United Kingdom, NR31 6LA|
|Contact: Shalal Sadullah, MD 44-01-493-452-827 email@example.com|
|Norfolk and Norwich University Hospital||Recruiting|
|Norwich, England, United Kingdom, NR4 7UY|
|Contact: Contact Person 44-160-328-7866 Jennie.firstname.lastname@example.org|
|Plymouth, England, United Kingdom, PL6 8DH|
|Contact: Simon Rule, MD 44-1752-517-505|
|Prescot Merseyside, England, United Kingdom, L35 5DR|
|Contact: Gnanam Satchi, MD 44-151-430-1825|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Contact Person 44-238-079-6185 email@example.com|
|Sunderland Royal Hospital||Recruiting|
|Sunderland, England, United Kingdom, SR4 7TP|
|Contact: Lucy Pemberton, MD 44-191-565-6256|
|Musgrove Park Hospital||Recruiting|
|Taunton, England, United Kingdom, TA1 5DA|
|Contact: Contact Person 44-182-334-2270 firstname.lastname@example.org|
|Torquay, England, United Kingdom, TQ2 7AA|
|Contact: Deborah Turner 44-180-365-5244 email@example.com|
|Royal Cornwall Hospital||Recruiting|
|Truro, Cornwall, England, United Kingdom, TR1 3LJ|
|Contact: Anton Kruger 44-187-225-2506 firstname.lastname@example.org|
|Aberdeen Royal Infirmary||Recruiting|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Contact: Contact Person 44-122-455-3394 email@example.com|
|Inverness, Scotland, United Kingdom, 1V2 3UJ|
|Contact: Contact Person 44-146-370-4258 firstname.lastname@example.org|
|Bangor, Wales, United Kingdom, LL57 2PW|
|Contact: Contact Person 44-1248-38-43-69 email@example.com|
|Prince Philip Hospital||Recruiting|
|Llanelli, Wales, United Kingdom, SA14 8QF|
|Contact: Contact Person 44-1554-75-65-67 firstname.lastname@example.org|
|Study Chair:||Simon Rule, MD||Derriford Hospital|