Clinical trial NCT02896582 (phase 2, status: active, not recruiting)
Conditions: mantle cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: obinutuzumab, dexamethasone, aracytine, cisplatinum, etoposide, melphalan, carmustine
SMILES: C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, ClCCNC(=O)N(CCCl)N=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 and age ≤ 65

          -  Histologically confirmed (according to the World Health Organization (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 untreated MCL

          -  Stage Ann Arbor II-IV in need of treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

          -  Life expectancy of more than 3 months

          -  Written informed consent

          -  Patient affiliated by any social security system

        Exclusion Criteria:

          -  Severe cardiac disease: York Heart Association (NYHA) grade 3-4

          -  Impaired liver (ALanine Amino Transferase (ALAT)/ASparagin Amino Transferase (ASAT) ≥
             2.5 Upper Limit of Normal (ULN), bilirubin ≥ 1.5 ULN), renal (calculated creatinine
             clearance < 50 ml/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

          -  Patients with a malignancy that has been treated but not with curative intent, unless
             the malignancy has been in remission without treatment for ≥ 5 years prior to
             enrollment. 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.

          -  Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (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)

          -  Vaccination with a live vaccine a minimum of 28 days prior to inclusion (Prolonged B
             cell depletion)

          -  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