Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

This study is currently recruiting participants.
Verified October 2012 by Plymouth Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00513955
First received: August 8, 2007
Last updated: October 29, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Plymouth Hospitals NHS Trust:

Primary Outcome Measures:
  • 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
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513955

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    
Sponsors and Collaborators
Plymouth Hospitals NHS Trust
Investigators
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