Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT ID: NCT00513955
Last Updated: 2014-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2006-06-30
2014-10-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bortezomib plus CHOP
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.
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.
bortezomib
cyclophosphamide
doxorubicin hydrochloride
prednisolone
vincristine sulfate
questionnaire administration
quality-of-life assessment
Interventions
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bortezomib
cyclophosphamide
doxorubicin hydrochloride
prednisolone
vincristine sulfate
questionnaire administration
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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:
* 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
18 Years
ALL
No
Sponsors
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University Hospital Plymouth NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Simon Rule, MD
Role: STUDY_CHAIR
Derriford Hospital
Locations
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Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Darent Valley Hospital
Dartford, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Guy's Hospital
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
James Paget Hospital
Norfolk, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Whiston Hospital
Prescot Merseyside, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Prince Philip Hospital
Llanelli, Wales, United Kingdom
Countries
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References
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Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. doi: 10.1111/bjh.13101. Epub 2014 Aug 22.
Other Identifiers
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NCRN-Ply-26s
Identifier Type: -
Identifier Source: secondary_id
EU-20747
Identifier Type: -
Identifier Source: secondary_id
ISRCTN200600609024
Identifier Type: -
Identifier Source: secondary_id
CDR0000559820
Identifier Type: -
Identifier Source: org_study_id
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