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Mantle Cell LymphomaPhase 2RIBVDNCT01457144

Study of Mantle Cell Lymphoma Treatment by RiBVD

A Phase 2 study testing RiBVD in people with Mantle Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
RiBVD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteFrance
Study dates
Oct 2011to Mar 2016
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 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • mantle cell Lymphoma CD20 positive
  • Untreated patients
  • 65 ans years old patients or 18 to 65 years old patients who can't or refuse receive conditioning regimen followed by autograft.
  • Stages Ann Arbor II, III or IV,
  • ECOG performance status of 0, 1 or 2
  • Without history of neoplasm, except in situ cervix carcinoma and cutaneous basal cell epithelioma, or in complete remission since 3 years,
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  • Without drug contraindication used in the schema (Rituximab, benda-mustine, Velcade, Dexamethasone),
  • Without heart insufficiency or stabilized,
  • With the following biological values limits except if pathological values are due to Medullary invading or hypersplenism, hepatic involvement) :PNN more than 1 G/L, Platelets more than 50 G/L,Transaminases (SGOT and SGPT) and alkalin phosphatases alcalines less than 4 x normal,Bilirubin less than 3 x N,- Clearance creatinemia more than 20 mL/min
  • Hepatitis B negative serology unless the seropositivity is clearly linked to a vaccination.
  • Can be regularly followed
  • Who signed the informed consent,
  • Affiliated to a national insurance or such a same scheme .

Who cannot join

  • Other type of lymphoma than mantle cell lymphoma according to OMS 2008 classification
  • Patients in relapse, except those in relapse due to localized stade who only received locoregional irradiation or splenectomized,
  • Central nervous system localization in particular meninge,
  • Drug used in the schema contraindication Rituximab , Bendamustine , Velcade® or Dexamethasone
  • Non stable diabetes,
  • HIV positive or active hepatitis C or B
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  • ECOG performance status equal or more than 3
  • Peripheral neuropathy, whatever its origin, rated more than 2 from NCI
  • Non stabilized heart insufficiency,
  • Patient who can't receive hyperhydration in order to treat tumoral lysis syndrome or in prophylaxis,
  • Patient who can't, whatever the reason, be regularly followed,
  • Major patient who are on legal protection, or can't give their consent
  • Patient who has not signed the informed consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • Valerie ROLLAND NEYRET

    Grenoble, 38043

Other trials in France

About this study

Official title: First Line Mantle Cell Lymphoma (MCL) Treatment by RiBVD Schema in Patients Older Than 65 Years or 18 to 65 Years Old Who Cannot or Refuse Receive Conditioning Regimen Followed by Autograft

Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

Read the detailed description

Demonstration of Improvement of progression-free survival (PFS) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen

Being tested
RiBVD
Keywords
Mantle cell lymphoma, Rituximab, bendamustine, Velcade, Dexamethasone
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RiBVDDrug

    Every cycle:

    Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2

Study groups in NCT01457144
Study groupRoleWhat they receive
RiBVDExperimentalRituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
Receives: Drug: RiBVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of progression-free survival (PFS)

    Improvement of progression-free survival (PFS) compared to litterature data 6 months prolongation 24 months compared to 18 months obtained whatever the current regimen and in particular compared to RCHOP regimen in reference with Lenz JCO 2005

    Measured: 18 months

Secondary outcomes (7)

  1. Overall and complete response rate after 4 cures and 6 cures

    Overall and complete response rate after 4 cures equal intermediate response and after 6 cures equal final response according to Cheson 1999 criteria without Positron Emission Tomography and 2007 with Positron Emission Tomography

    Measured: 6 months

  2. Residual disease evaluated by molecular biology

    Residual disease evaluated by molecular biology on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells

    Measured: 6 years

  3. Intermediate response predictive factors study

    Predictive factors are determined at diagnosis are watched at Intermediate response

    Measured: 4 months

  4. Toxicity of RiBVD regimen according to NCI criteria Hematological and non-hematological toxicity

    Toxicities are collected at every course = every 28 days during 6 months

    Measured: 6 months

  5. Prognosis value on Overall survival and progression free survival and on duration of response, of the MIPI index, MIPIb index and goelams index

    Measured: 36 months

  6. Residual disease evaluated by molecular biology Q-PCR on blood and bone marrow, by Hybridation Fluorescente In Situ and Flow cytometry on blood cells

    blood and bone marrow samples sent to central laboratory for molecular residual disease at diagnosis, treatment evaluation and follow-up

    Measured: 42 months

  7. Diagnostic PET scan results, at intermediate and final analysis

    Pet scan results at intermediate analysis = 4 months Pet scan results at final analysis = 6 months

    Measured: 4 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2014
  4. Study completionMar 2016

Resources

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
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457144
Sponsor's protocol ID
Manteau RiBVD
Acronym
RIBVD
Status last verified
Mar 2016
First submitted
20 Oct 2011
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RiBVD in people with Mantle Cell 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?

The sponsor lists 13 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 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?

Improvement of progression-free survival (PFS) (time frame: 18 months). 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 NCT01457144.

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.

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