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Mantle Cell LymphomaPhase 2LyMa101NCT02896582

Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance

A Phase 2 study testing Obinutuzumab, Dexamethasone and Aracytine in people with Mantle Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Obinutuzumab, Dexamethasone and Aracytine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
30 sitesFrance
Study dates
29 Nov 2016to 2 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • CHU d'Amiens

    Amiens, 80480

  • CHU d'Angers

    Angers, 49000

  • CH d'Avignon

    Avignon, 84902

  • CHU de Caen

    Caen, 14033

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63000

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21034

  • CHU de Grenoble

    Grenoble, 38700

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo

    Le Mans, 72000

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • CHU Montpellier

    Montpellier, 34295

  • CHU Nantes

    Nantes, 44093

  • Hôpital Saint Louis

    Paris, 75475

  • APHP - Hopital Necker

    Paris, 75743

  • CH Perpignan

    Perpignan, 66046

  • CHU de Haut Leveque

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69130

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Annecy-Genevois

    Pringy, 74374

  • CHU Robert Debré

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271

  • CHU de Strasbourg

    Strasbourg, 67091

  • I.U.C.T Oncopole

    Toulouse, 31100

  • CHRU Bretonneau

    Tours, 37044

  • CHU de Brabois

    Vandœuvre-lès-Nancy

  • Gustave Roussy Cancer Campus

    Villejuif, 94805

Other trials in France

About this study

Official title: Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance

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

Read the detailed description

Patients will be recruited over 2 years. They must have a histologically proven diagnosis of mantle cell lymphoma, be aged from 18 to 65 years at the time of registration. Patients must be eligible for autologous transplant and not previously treated for their lymphoma at inclusion. Patients will receive 4 cycles of Obinutuzumab (GA101) and Cisplatinum-Cytarabine-Dexamethasone (GA-DHAP) every 21 days followed by Autologous Stem Cell Transplant (ASCT) using a GA101-Carmustine- Etoposide- Cytarabine- Melphalan (GA-BEAM) conditioning regimen plus a Obinutuzumab maintenance for 3 years then a Obinutuzumab maintenance on demand according to MRD status. Stem cells will be collected after cycle 3 and/or 4 of GA-DHAP.

Being tested
Obinutuzumab, Dexamethasone, Aracytine, Cisplatinum, Etoposide
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called GA, GA101

    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+

  • DexamethasoneDrug

    40 mg D1 to D4 in GA-DHAP

  • AracytineDrug

    Also called Cytarabine

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

  • CisplatinumDrug

    100 mg/m² D1 in GA-DHAP

  • EtoposideDrug

    400 mg/m² D-6 to D-3 in GA-BEAM

  • MelphalanDrug

    140 mg/m² D-2 in GA-BEAM

  • CarmustineDrug

    Also called BiCNU, BCNU

    300 mg/m² D-7 in GA-BEAM

Study groups in NCT02896582
Study groupRoleWhat they receive
Induction - ASCT - maintenanceExperimentalInduction : 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
Receives: Drug: Obinutuzumab; Drug: Dexamethasone; Drug: Aracytine; Drug: Cisplatinum; Drug: Etoposide; Drug: Melphalan; Drug: Carmustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 cycles (1 cycle is 21 days)

Secondary outcomes (16)

  1. Response according to Cheson 99

    Response after 2.5 years of treatment and 3 years of maintenance will be evaluated. Assessment of response will be based on the International Workshop to Standardize Response criteria for Non Hodgkin Lymphoma (NHL) (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999)

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

  2. Overall response rate (ORR)

    Response after 2.5 years of treatment and 3 years of maintenance will be evaluated. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999)

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

  3. Positron Emission Tomography (PET) result

    PET result after 2.5 years of treatment and 3 years of maintenance will be evaluated. Assessment of PET will be based on Lugano 2014 criteria (according to Cheson \& al. Journal of Clinical Oncology 2015).

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

  4. MRD

    Molecular residual disease (MRD) after 2.5 years of treatment and 3 years of maintenance will be evaluated. Assessment of MRD will be based on molecular level in bone marrow (BM) according to the European Mantle Cell Lymphoma network (EU-MCL) guidelines.

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

  5. MRD and after maintenance "on demand"

    Molecular residual disease (MRD) after maintenance "on demand" will be evaluated. Assessment of MRD will be based on molecular level in BM according to EU MCL network guidelines.

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

  6. Progression Free Survival (PFS)

    PFS is defined as the time from inclusion into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment.

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

  7. Overall survival (OS)

    OS will be measured from the date of inclusion to the date of death from any cause. Alive patients will be censored at their last contact date

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

  8. Number of patients for whom stemm cell collection will fail

    Stem cell collection failure will be evaluated after induction treatment

    Measured: 3 years

  9. Duration of MRD negativity

    Duration of MRD negativity is defined as the time from the date of attainment the first negative MRD to the date of positive MRD. Duration or MRD negativity would be assessed for patients with at least one MRD negativity and as survival endpoint.

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

  10. Treatment duration

    Measured: 9 years

  11. Average dose

    Measured: 9 years

  12. Number of premature treatment discontinuation

    Measured: 9 years

  13. Frequency of premature treatment discontinuation

    Measured: 9 years

  14. Number of study discontinuation

    Measured: 9 years

  15. Frequency of study discontinuation

    Measured: 9 years

  16. Number of adverse events

    Measured: 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study start29 Nov 2016
  3. Primary completionMar 2019
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896582
Sponsor's protocol ID
LyMa101
Acronym
LyMa101
Status last verified
Jan 2026
First submitted
6 Sep 2016
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38669626

  • 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.

    PubMed 37875524

  • 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.

    PubMed 32971036

  • 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.

    PubMed 31371411

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab, Dexamethasone and Aracytine in people with Mantle Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Molecular Residual Disease (MRD) in bone marrow after 4 cycles of GA-DHAP (time frame: 4 cycles (1 cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02896582, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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