Clinical trial · Interventional
Study of Mantle Cell Lymphoma Treatment by RiBVD
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
NCT01457144CI-TRIAL-00021374RIBVDcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RiBVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RiBVD
- description
- Rituximab Bendamustine Velcade® Dexamethasone 6 cycles every 28 days
- interventionNames
- Drug: RiBVD
Primary outcomes (1)
- measure
- Improvement of progression-free survival (PFS)
- timeFrame
- 18 months
- 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
Secondary outcomes (7)
- measure
- Overall and complete response rate after 4 cures and 6 cures
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.