Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance
NCT ID: NCT02896582
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2016-11-29
2024-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Induction - ASCT - maintenance
Induction : 4 cycles of GA-DHAP every 21 days - Conditioning regimen and ASCT: GA-BEAM + Autologous transplantation - Maintenance : Obinutuzumab every 2 months for 3 years then every month for patients with positive MRD
Obinutuzumab
1000 mg D1, D8, D15 in GA-DHAP 1000 mg D-8 in GA-BEAM 1000 mg every 2 months for 3 years then every month if MRD+
Dexamethasone
40 mg D1 to D4 in GA-DHAP
Aracytine
2g/m² D1 \& D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM
Cisplatinum
100 mg/m² D1 in GA-DHAP
Etoposide
400 mg/m² D-6 to D-3 in GA-BEAM
Melphalan
140 mg/m² D-2 in GA-BEAM
Carmustine
300 mg/m² D-7 in GA-BEAM
Interventions
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Obinutuzumab
1000 mg D1, D8, D15 in GA-DHAP 1000 mg D-8 in GA-BEAM 1000 mg every 2 months for 3 years then every month if MRD+
Dexamethasone
40 mg D1 to D4 in GA-DHAP
Aracytine
2g/m² D1 \& D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM
Cisplatinum
100 mg/m² D1 in GA-DHAP
Etoposide
400 mg/m² D-6 to D-3 in GA-BEAM
Melphalan
140 mg/m² D-2 in GA-BEAM
Carmustine
300 mg/m² D-7 in GA-BEAM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Steven Le Gouill, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Olivier Hermine, Pr
Role: PRINCIPAL_INVESTIGATOR
Hopital Necker - Paris
Locations
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CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CH d'Avignon
Avignon, , France
CHU de Caen
Caen, , France
CHU de Clermont Ferrand
Clermont-Ferrand, , France
Hopital Henri Mondor
Créteil, , France
CHU de Dijon - Hôpital le Bocage
Dijon, , France
CHU de Grenoble
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
CHRU Lille - Hôpital Claude Huriez
Lille, , France
CHU Limoges
Limoges, , France
CHU Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Hôpital Saint Louis
Paris, , France
APHP - Hopital Necker
Paris, , France
CH Perpignan
Perpignan, , France
CHU de Haut Leveque
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier Annecy-Genevois
Pringy, , France
CHU Robert Debré
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, , France
CHU de Strasbourg
Strasbourg, , France
I.U.C.T Oncopole
Toulouse, , France
CHRU Bretonneau
Tours, , France
CHU de Brabois
Vandœuvre-lès-Nancy, , France
Gustave Roussy Cancer Campus
Villejuif, , France
Countries
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References
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Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.
Bodet-Milin C, Morvant C, Carlier T, Frecon G, Tournilhac O, Safar V, Kraeber-Bodere F, Le Gouill S, Macintyre E, Bailly C. Performance of baseline FDG-PET/CT radiomics for prediction of bone marrow minimal residual disease status in the LyMa-101 trial. Sci Rep. 2023 Oct 24;13(1):18177. doi: 10.1038/s41598-023-45215-y.
Le Gouill S, Beldi-Ferchiou A, Alcantara M, Cacheux V, Safar V, Burroni B, Guidez S, Gastinne T, Canioni D, Thieblemont C, Maisonneuve H, Bodet-Milin C, Houot R, Oberic L, Bouabdallah K, Bescond C, Damaj G, Jaccard A, Daguindau N, Moreau A, Tilly H, Ribrag V, Delfau-Larue MH, Hermine O, Macintyre E. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group. Lancet Haematol. 2020 Nov;7(11):e798-e807. doi: 10.1016/S2352-3026(20)30291-X. Epub 2020 Sep 21.
Bailly C, Carlier T, Berriolo-Riedinger A, Casasnovas O, Gyan E, Meignan M, Moreau A, Burroni B, Djaileb L, Gressin R, Devillers A, Lamy T, Thieblemont C, Hermine O, Kraeber-Bodere F, Le Gouill S, Bodet-Milin C. Prognostic value of FDG-PET in patients with mantle cell lymphoma: results from the LyMa-PET Project. Haematologica. 2020 Jan;105(1):e33-e36. doi: 10.3324/haematol.2019.223016. Epub 2019 Aug 1. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LyMa101
Identifier Type: -
Identifier Source: org_study_id
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