NCT02896582

Brief Summary

This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_2

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 29, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

September 6, 2016

Last Update Submit

January 12, 2026

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Molecular Residual Disease (MRD) in bone marrow after 4 cycles of GA-DHAP

    to evaluate the efficacy of upfront Obinutuzumab (GA101) at the molecular level (MRD) in bone marrow after induction in patients with previously untreated Mantle Cell Lymphoma (MCL) treated by DHAP

    4 cycles (1 cycle is 21 days)

Secondary Outcomes (16)

  • Response according to Cheson 99

    5.5 years (2.5 years of treatment and 3 years of maintenance)

  • Overall response rate (ORR)

    5.5 years (2.5 years of treatment and 3 years of maintenance)

  • Positron Emission Tomography (PET) result

    5.5 years (2.5 years of treatment and 3 years of maintenance)

  • MRD

    5.5 years (2.5 years of treatment and 3 years of maintenance)

  • MRD and after maintenance "on demand"

    8.5 years (2.5 years of treatment and 2x3 years of maintenance)

  • +11 more secondary outcomes

Study Arms (1)

Induction - ASCT - maintenance

EXPERIMENTAL

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

Drug: ObinutuzumabDrug: DexamethasoneDrug: AracytineDrug: CisplatinumDrug: EtoposideDrug: MelphalanDrug: Carmustine

Interventions

ObinutuzumabDRUG

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+

Also known as: GA, GA101
Induction - ASCT - maintenance
DexamethasoneDRUG

40 mg D1 to D4 in GA-DHAP

Induction - ASCT - maintenance
AracytineDRUG

2g/m² D1 \& D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM

Also known as: Cytarabine
Induction - ASCT - maintenance
CisplatinumDRUG

100 mg/m² D1 in GA-DHAP

Induction - ASCT - maintenance
EtoposideDRUG

400 mg/m² D-6 to D-3 in GA-BEAM

Induction - ASCT - maintenance
MelphalanDRUG

140 mg/m² D-2 in GA-BEAM

Induction - ASCT - maintenance
CarmustineDRUG

300 mg/m² D-7 in GA-BEAM

Also known as: BiCNU, BCNU
Induction - ASCT - maintenance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

CHU d'Amiens

Amiens, 80480, France

Location

CHU d'Angers

Angers, 49000, France

Location

CH d'Avignon

Avignon, 84902, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon - Hôpital le Bocage

Dijon, 21034, France

Location

CHU de Grenoble

Grenoble, 38700, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

CHRU Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU Limoges

Limoges, 87042, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

APHP - Hopital Necker

Paris, 75743, France

Location

CH Perpignan

Perpignan, 66046, France

Location

CHU de Haut Leveque

Pessac, 33604, France

Location

CHU Lyon Sud

Pierre-Bénite, 69130, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Annecy-Genevois

Pringy, 74374, France

Location

CHU Robert Debré

Reims, 51092, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancérologie de Loire

Saint-Priest-en-Jarez, 42271, France

Location

CHU de Strasbourg

Strasbourg, 67091, France

Location

I.U.C.T Oncopole

Toulouse, 31100, France

Location

CHRU Bretonneau

Tours, 37044, France

Location

CHU de Brabois

Vandœuvre-lès-Nancy, France

Location

Gustave Roussy Cancer Campus

Villejuif, 94805, France

Location

Related Publications (4)

  • 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.

    PMID: 38669626DERIVED

  • 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.

    PMID: 37875524DERIVED

  • 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.

    PMID: 32971036DERIVED

  • 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.

    PMID: 31371411DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

obinutuzumabDexamethasoneCytarabineCisplatinEtoposideMelphalanCarmustine

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsNitrosourea CompoundsUreaAmidesNitroso Compounds

Study Officials

  • Steven Le Gouill, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Olivier Hermine, Pr

    Hopital Necker - Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 12, 2016

Study Start

November 29, 2016

Primary Completion

March 1, 2019

Study Completion

December 2, 2024

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(30)