Mantle Cell Lymphoma MedDRA version: 19.0 Level: PT Classification code 10061275 Term: Mantle cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GAZYVARO
Product Name: Obinutuzumab
Product Code: GA101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Obinutuzumab
CAS Number: 949142-50-1
Current Sponsor
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 and age = 65 • Histologically confirmed (according to the WHO classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation. • Bone marrow aspiration performed at inclusion for MRD analyses • Eligible for autologous stem cell transplant • Previously Uuntreated MCL • Stage Ann Arbor II-IV in need of treatment • ECOG performance status of 0 – 2 • Life expectancy of more than 3 months • Written informed consent • Patient covered by any social security system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 83 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe cardiac disease: NYHA grade 3-4 • Impaired liver (ALAT/ASAT = 2.5ULN, bilirubin = 1.5ULN), renal (calculated creatinine clearance < 50ml/min) or other organ function which will interfere with the treatment, if not related to lymphoma. • History of chronic liver disease • Hepatic veno-occlusive disease or sinusoidal obstruction syndrome • Any of the following laboratory abnormalities, if not result of a BM infiltration: - Absolute neutrophils count (ANC) <1,500 /mm3 (1.5 x 109/L) - Platelet counts < 75,000/mm3 (75 x 109/L) • Pregnancy/Nursing mothers • Fertile men or women of childbearing potential unless: - surgically sterile or = 2 years after the onset of menopause - willing to use a highly effective contraceptive method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly during study treatment and in female patients for 18 months after end of antibody treatment • Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Patients with a malignancy that has been treated but not with curative intent will also be excluded, unless the malignancy has been in remission without treatment for = 5 years prior to enrollment • Known seropositivity for HIV, HCV or other active infection uncontrolled by treatment. • Viral infection with hepatitis B virus (HBV) defined as hepatitis B surface antigen (HBsAg) positive and/or Hepatitis B core antibody (anti-HBc) positive Note: Patients who are immune due to hepatitis B vaccination or natural infection (HBs Ag and anti-HBc negative, anti-HBs positive) are eligible. But the patients who are immune due to hepatitis B natural infection should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation • Prior history of Progressive Multifocal Leukoencephalopathy (PML) • Prolonged B cell depletion • Vaccination with a live vaccine a minimum of 28 days prior to inclusion • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products • Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study. • Person deprived of his/her liberty by a judicial or administrative decision • Person hospitalized without consent • Adult person under legal protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of upfront Obinutuzumab (GA101) at the molecular level (MRD) in bone marrow after induction in patients with previously untreated MCL treated by DHAP.;Secondary Objective: Secondary objectives: •To evaluate the efficacy of the obinutuzumab in patients with MCL treated by DHAP before ASCT, after ASCT and every 6 months in terms of clinical response (Cheson 99), FDG-PET and MRD •To evaluate PFS, Overall survival at study end •To evaluate the incidence of stem cell collection failure after obinutuzumab-DHAP = GA-DHAP •To evaluate MRD negativity after 3 years of maintenance and maintenance “on-demand” •To evaluate PET results after 3 years of maintenance •Duration of MRD negativity •To evaluate tolerability of obinutuzumab at induction and then “on-demand” Exploratory objective: • To determine baseline prognostic factors on PFS and OS. ;Primary end point(s): MRD;Timepoint(s) of evaluation of this end point: - every 6 months during 3 years then every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •clinical response (Cheson 99), FDG-PET •PFS, Overall survival •incidence of stem cell collection failure •MRD negativity •PET results •Duration of MRD negativity •tolerability of obinutuzumab •baseline prognostic factors on PFS and OS;Timepoint(s) of evaluation of this end point: •clinical response (Cheson 99), FDG-PET = every 6 months •PFS, Overall survival = study end •incidence of stem cell collection failure = after obinutuzumab-DHAP •MRD negativity = after 3 years of maintenance and maintenance “on-demand” •PET results = after 3 years of maintenance •duration of MRD negativity = over the study •tolerability of obinutuzumab = at induction and then “on-demand” •baseline prognostic factors on PFS and OS = end of study | — |
Countries
France
Contacts
Public ContactManagement de Projet S. Doyen
LYSARC
Outcome results
None listed