LymphomaPhase 2ManteauRiBVDNCT00740415
Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma
A Phase 2 study testing rituximab, bortezomib and dexamethasone in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, bortezomib and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Aug 2015
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of mantle cell lymphoma
- Stage II-IV disease
- No neuromeningeal disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer
- LVEF > 50%
- HIV-negative
- Hepatitis B- and C-negative
- No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-line Treatment of Mantle Cell Lymphoma of Old Patients . Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.
Secondary
- Determine the complete response rate in these patients.
- Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
- Determine overall, disease-free, and event-free survival of these patients.
- Assess tolerability of this regimen in these patients.
- Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
- Assess the impact of residual disease in cerebrospinal fluid on survival.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least 50% response receive 2 additional courses of therapy.
- Conditions
- Lymphoma
- Being tested
- rituximab, bortezomib, dexamethasone, Bendamustine
- Keywords
- contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV 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.
rituximabBiological
Also called Mabthera ®,
Rituximab, 375 mg/m2 Intraveinous
bortezomibDrug
Also called Velcade
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
dexamethasoneDrug
day - Dexamethasone, 40 mg Intraveinous
BendamustineDrug
Also called Levact ®
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
| Study group | Role | What they receive |
|---|---|---|
| ARM RiBVD | Experimental | RiBVD 6 cycles every 28 days day 1 :
* Rituximab /Mabthera®, 375 mg/m2 en IV
* Bendamustine, 90 mg/m2 en IVD
* Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 2 : - Bendamustine, 90 mg/m2 en IVD
* Dexamethasone, 40 mg IV day 4 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 8 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 11 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD Receives: Biological: rituximab; Drug: bortezomib; Drug: dexamethasone; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate after 4 courses of therapy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2011
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, Mundipharma Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Remy Gressin, MD, Study chair, CHU de Grenoble - Hopital de la Tronche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740415
- Sponsor's protocol ID
- CDR0000589544
- Other IDs
- -MANTEAU-2010-SA
- Acronym
- ManteauRiBVD
- Status last verified
- Mar 2016
- First submitted
- 22 Aug 2008
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Treatment of Mantle Cell Lymphoma of Old Patients . Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab
- ClinicalTrials.gov ID
- NCT00740415
- Acronym / sponsor ID
- ManteauRiBVD / CDR0000589544
- Conditions
- Lymphoma
- Keywords
- contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Janssen, LP, Mundipharma Pte Ltd.
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Aug 2008 (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: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.
Secondary
- Determine the complete response rate in these patients.
- Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
- Determine overall, disease-free, and event-free survival of these patients.
- Assess tolerability of this regimen in these patients.
- Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
- Assess the impact of residual disease in cerebrospinal fluid on survival.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least 50% response receive 2 additional courses of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM RiBVD | Experimental | Biological: rituximab, Drug: bortezomib, Drug: dexamethasone, Drug: BendamustineRiBVD 6 cycles every 28 days day 1 : * Rituximab /Mabthera®, 375 mg/m2 en IV * Bendamustine, 90 mg/m2 en IVD * Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 2 : - Bendamustine, 90 mg/m2 en IVD * Dexamethasone, 40 mg IV day 4 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 8 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 11 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| rituximabAlso: Mabthera ®,Rituximab, 375 mg/m2 Intraveinous | Biological | ARM RiBVD |
| bortezomibAlso: Velcade-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11 | Drug | ARM RiBVD |
| dexamethasoneday - Dexamethasone, 40 mg Intraveinous | Drug | ARM RiBVD |
| BendamustineAlso: Levact ®-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous | Drug | ARM RiBVD |
Primary outcome
Overall response rate after 4 courses of therapy
Time frame: 4 months
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 16 Mar 2016.
- FILO websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Remy Gressin, MD study chair
CHU de Grenoble - Hopital de la Tronche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, bortezomib and dexamethasone in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Overall response rate after 4 courses of therapy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2016.