LymphomaPhase 2NCT00513955
Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study testing bortezomib, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by University Hospital Plymouth NHS Trust at 25 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bortezomib, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- Jun 2006to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United Kingdom25 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Good Hope Hospital
Birmingham, England, B75 7RR
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Darent Valley Hospital
Dartford, England, DA2 8DA
Harrogate District Hospital
Harrogate, England, HG2 7SX
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Leeds General Infirmary
Leeds, England, LS1 3EX
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Prince Philip Hospital
Llanelli, Wales, SA14 8QF
Guy's Hospital
London, England, SE1 9RT
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ
Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
James Paget Hospital
Norfolk, England, NR31 6LA
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Derriford Hospital
Plymouth, England, PL6 8DH
Whiston Hospital
Prescot Merseyside, England, L35 5DR
Southampton General Hospital
Southampton, England, SO16 6YD
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
Musgrove Park Hospital
Taunton, England, TA1 5DA
Torbay Hospital
Torquay, England, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
About this study
Official title: A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed 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. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.
Read the 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 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
- Lymphoma
- Being tested
- bortezomib, cyclophosphamide, doxorubicin hydrochloride, prednisolone, vincristine sulfate
- Keywords
- recurrent mantle cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
cyclophosphamideDrug
prednisoloneDrug
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib plus CHOP | Experimental | 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. Receives: Drug: bortezomib; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisolone; Drug: vincristine sulfate; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
Measured: 30 days and every 12 weeks
Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
Measured: continual after first drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJun 2006
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Rule, MD, Study chair, Derriford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513955
- Sponsor's protocol ID
- CDR0000559820
- Other IDs
- NCRN-Ply-26s, EU-20747, ISRCTN200600609024
- Status last verified
- Nov 2014
- First submitted
- 8 Aug 2007
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25146720
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00513955
- Acronym / sponsor ID
- CDR0000559820
- Conditions
- Lymphoma
- Keywords
- recurrent mantle cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib plus CHOP | Experimental | Drug: bortezomib, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisolone, Drug: vincristine sulfate, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib | Drug | Bortezomib plus CHOP |
| cyclophosphamide | Drug | Bortezomib plus CHOP |
| doxorubicin hydrochloride | Drug | Bortezomib plus CHOP |
| prednisolone | Drug | Bortezomib plus CHOP |
| vincristine sulfate | Drug | Bortezomib plus CHOP |
| questionnaire administration | Other | Bortezomib plus CHOP |
| quality-of-life assessment | Procedure or surgery | Bortezomib plus CHOP |
Primary outcome
Disease progression
Time frame: 30 days and every 12 weeks
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0
Time frame: continual after first drug dose
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Results publication: PubMed 25146720Furtado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Rule, MD study chair
Derriford Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by University Hospital Plymouth NHS Trust at 25 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: 30 days and every 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.