Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance (LyMa101)

January 12, 2026 updated by: The Lymphoma Academic Research Organisation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • CHU d'Amiens
      • Angers, France, 49000
        • CHU d'Angers
      • Avignon, France, 84902
        • CH d'Avignon
      • Caen, France, 14033
        • CHU de CAEN
      • Clermont-Ferrand, France, 63000
        • Chu de Clermont Ferrand
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Dijon, France, 21034
        • CHU de Dijon - Hôpital le Bocage
      • Grenoble, France, 38700
        • CHU de Grenoble
      • La Roche-sur-Yon, France, 85925
        • CHD Vendée
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille, France, 59037
        • CHRU Lille - Hôpital Claude Huriez
      • Limoges, France, 87042
        • CHU Limoges
      • Montpellier, France, 34295
        • CHU Montpellier
      • Nantes, France, 44093
        • CHU Nantes
      • Paris, France, 75475
        • Hôpital Saint Louis
      • Paris, France, 75743
        • APHP - Hôpital Necker
      • Perpignan, France, 66046
        • CH Perpignan
      • Pessac, France, 33604
        • CHU de Haut Leveque
      • Pierre-Bénite, France, 69130
        • CHU Lyon Sud
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Pringy, France, 74374
        • Centre Hospitalier Annecy-Genevois
      • Reims, France, 51092
        • CHU Robert Debré
      • Rennes, France, 35033
        • CHU Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Priest-en-Jarez, France, 42271
        • Institut de Cancérologie de Loire
      • Strasbourg, France, 67091
        • CHU de Strasbourg
      • Toulouse, France, 31100
        • I.U.C.T Oncopole
      • Tours, France, 37044
        • CHRU Bretonneau
      • Vandœuvre-lès-Nancy, France
        • CHU de Brabois
      • Villejuif, France, 94805
        • Gustave Roussy Cancer Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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+
Other Names:
  • GA
  • GA101
Drug: Dexamethasone
40 mg D1 to D4 in GA-DHAP
Drug: Aracytine
2g/m² D1 & D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM
Other Names:
  • Cytarabine
Drug: Cisplatinum
100 mg/m² D1 in GA-DHAP
Drug: Etoposide
400 mg/m² D-6 to D-3 in GA-BEAM
Drug: Melphalan
140 mg/m² D-2 in GA-BEAM
Drug: Carmustine
300 mg/m² D-7 in GA-BEAM
Other Names:
  • BCNU
  • BiCNU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Molecular Residual Disease (MRD) in bone marrow after 4 cycles of GA-DHAP
Time Frame: 4 cycles (1 cycle is 21 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Response according to Cheson 99
Time Frame: 5.5 years (2.5 years of treatment and 3 years of maintenance)
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)
5.5 years (2.5 years of treatment and 3 years of maintenance)
Overall response rate (ORR)
Time Frame: 5.5 years (2.5 years of treatment and 3 years of maintenance)
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)
5.5 years (2.5 years of treatment and 3 years of maintenance)
Positron Emission Tomography (PET) result
Time Frame: 5.5 years (2.5 years of treatment and 3 years of maintenance)
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).
5.5 years (2.5 years of treatment and 3 years of maintenance)
MRD
Time Frame: 5.5 years (2.5 years of treatment and 3 years of maintenance)
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.
5.5 years (2.5 years of treatment and 3 years of maintenance)
MRD and after maintenance "on demand"
Time Frame: 8.5 years (2.5 years of treatment and 2x3 years of maintenance)
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.
8.5 years (2.5 years of treatment and 2x3 years of maintenance)
Progression Free Survival (PFS)
Time Frame: 8.5 years (2.5 years of treatment and 2x3 years of maintenance)
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.
8.5 years (2.5 years of treatment and 2x3 years of maintenance)
Overall survival (OS)
Time Frame: 8.5 years (2.5 years of treatment and 2x3 years of maintenance)
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
8.5 years (2.5 years of treatment and 2x3 years of maintenance)
Number of patients for whom stemm cell collection will fail
Time Frame: 3 years
Stem cell collection failure will be evaluated after induction treatment
3 years
Duration of MRD negativity
Time Frame: 8.5 years (2.5 years of treatment and 2x3 years of maintenance)
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.
8.5 years (2.5 years of treatment and 2x3 years of maintenance)
Treatment duration
Time Frame: 9 years
9 years
Average dose
Time Frame: 9 years
9 years
Number of premature treatment discontinuation
Time Frame: 9 years
9 years
Frequency of premature treatment discontinuation
Time Frame: 9 years
9 years
Number of study discontinuation
Time Frame: 9 years
9 years
Frequency of study discontinuation
Time Frame: 9 years
9 years
Number of adverse events
Time Frame: 9 years
9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Lymphoma Academic Research Organisation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Hermine, Pr, Hopital Necker - Paris
  • Principal Investigator: Steven Le Gouill, Pr, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LyMa101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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