Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Other: questionnaire administration Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | June 2014 |
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of mantle cell lymphoma (MCL)
- Expression of cyclin D1 or evidence of t(11;14) translocation by cytogenetics, FISH, or polymerase chain reaction
- Refractory to or relapsed or progressed after first line antineoplastic therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- ANC ≥ 1,000/mm³ (not related to lymphoma)
- Platelet count ≥ 30,000/mm³
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Total bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 20 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion criteria:
- Known serological positivity for HBV, HCV, or HIV
- History of allergic reaction attributable to compounds containing boron or mannitol
- Diagnosed or treated for a malignancy other than MCL within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or any in situ malignancy
- Active systemic infection requiring treatment
- Serious medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- Toxic effects of prior therapy or surgery must be resolved to ≤ grade 2
- Prior splenectomy or localized radiotherapy allowed
Any prior chemotherapy regimen allowed
- Chemotherapy may have been given in combination with rituximab
- Concurrent enrollment in a nontreatment study allowed, provided it does not interfere with participation in this study
Exclusion criteria:
- Prior bortezomib
- Antineoplastic therapy within the past 3 weeks
- Nitrosoureas within the past 6 weeks
- Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody within the past 4 weeks
- Radiotherapy within the past 3 weeks
- Major surgery within the past 2 weeks
- Concurrent investigational agents
Contacts and Locations| United Kingdom | |
| Basingstoke and North Hampshire NHS Foundation Trust | Recruiting |
| Basingstoke, England, United Kingdom, RG24 9NA | |
| Contact: Contact Person 44-125-631-3282 alison.milne@bnhft.nhs.uk | |
| Good Hope Hospital | Recruiting |
| Birmingham, England, United Kingdom, B75 7RR | |
| Contact: Matthew A. Lumley, MD 44-121-378-6206 matthew.lumley@goodhope.nhs.uk | |
| 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 dr.macheta@bfwhospitals.nhs.uk | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Contact Person 44-122-324-5151 george.follows@addenbrookes.nhs.uk | |
| Darent Valley Hospital | Recruiting |
| Dartford, England, United Kingdom, DA2 8DA | |
| Contact: Contact Person 44-1322-428-508 tariq.shafi@dvh.nhs.uk | |
| 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 andrew.pettitt@rlbuht.nhs.uk | |
| Guy's Hospital | Recruiting |
| London, England, United Kingdom, SE1 9RT | |
| Contact: Contact Person 44-207-188-1421 paul.fields@gstt.sthames.nhs.uk | |
| Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Contact: Contact Person 44-162-222-5041 mehill@nhs.net | |
| Royal Victoria Infirmary | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Contact: Contact Person 44-191-282-9408 anne.lennard@nuth.nhs.uk | |
| James Paget Hospital | Recruiting |
| Norfolk, England, United Kingdom, NR31 6LA | |
| Contact: Shalal Sadullah, MD 44-01-493-452-827 shalal.sadullah@jiaget.nhs.uk | |
| Norfolk and Norwich University Hospital | Recruiting |
| Norwich, England, United Kingdom, NR4 7UY | |
| Contact: Contact Person 44-160-328-7866 Jennie.wimperis@nnuh.nhs.uk | |
| Derriford Hospital | Recruiting |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Contact: Simon Rule, MD 44-1752-517-505 | |
| Whiston Hospital | Recruiting |
| 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 johnsonp@soton.ac.uk | |
| 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 simon.bolam@tst.nhs.uk | |
| Torbay Hospital | Recruiting |
| Torquay, England, United Kingdom, TQ2 7AA | |
| Contact: Deborah Turner 44-180-365-5244 deborah.turner2@nhs.net | |
| Royal Cornwall Hospital | Recruiting |
| Truro, Cornwall, England, United Kingdom, TR1 3LJ | |
| Contact: Anton Kruger 44-187-225-2506 anton.kruger@rcht.cornwall.nhs.uk | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: Contact Person 44-122-455-3394 dominic.culligan@arh.grampian.scot.nhs.uk | |
| Raigmore Hospital | Recruiting |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| Contact: Contact Person 44-146-370-4258 peter.forsyth@haht.scot.nhs.uk | |
| Ysbyty Gwynedd | Recruiting |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Contact: Contact Person 44-1248-38-43-69 david.edwards@nww-tr.wales.nhs.uk | |
| Prince Philip Hospital | Recruiting |
| Llanelli, Wales, United Kingdom, SA14 8QF | |
| Contact: Contact Person 44-1554-75-65-67 sian.lewis@carmarthen.wales.nhs.uk | |
| Study Chair: | Simon Rule, MD | Derriford Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Plymouth Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00513955 History of Changes |
| Other Study ID Numbers: | CDR0000559820, NCRN-Ply-26s, EU-20747, ISRCTN200600609024 |
| Study First Received: | August 8, 2007 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Plymouth Hospitals NHS Trust:
|
recurrent mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Bortezomib Doxorubicin Prednisolone Methylprednisolone Hemisuccinate Vincristine |
Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013