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

NCT02896582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-01-14

No results posted yet for this study

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

Conditions

Interventions

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+

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

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

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Steven Le Gouill, Pr · Nantes University Hospital

  • Olivier Hermine, Pr · Hopital Necker - Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2019-03-31
Completion
2024-12-02

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896582 on ClinicalTrials.gov