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


Phase 2
65 Years
85 Years
Open (Enrolling)
Both
Mantle Cell Lymphoma

Thank you

Trial Information

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


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


Inclusion Criteria:



- 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,

- 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 .

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement of progression-free survival (PFS)

Outcome Description:

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

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Rémy GRESSIN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Est Ouest des Leucémies et autres Maladies du Sand

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Manteau RiBVD

NCT ID:

NCT01457144

Start Date:

October 2011

Completion Date:

April 2018

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Rituximab
  • bendamustine
  • Velcade
  • Dexamethasone
  • Lymphoma
  • Lymphoma, Mantle-Cell

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