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Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse

NCT03229382 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-08-16

No results posted yet for this study

Summary

The objective of the study is the evaluation of efficacy and safety of obinutuzumab preemptive treatment at the time of the molecular relapse after first line immunochemotherapy with autologous stem cell transplantation in mantle cell lymphoma patients.

Conditions

Interventions

DRUG

Obinutuzumab

Patients, in whom all inclusion criteria have been confirmed and all exclusion criteria have been ruled out, will receive 4 intravenous infusions of obinutuzumab (GA101, Gazyvaro) at a dose of 1000 mg on Days 1, 8, 15 and 22.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Polish Lymphoma Research Group

    lead NETWORK

Principal Investigators

  • Michał Szymczyk, MD · Institute of Oncology

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
2018-05-14
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Poland

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 NCT03229382 on ClinicalTrials.gov