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Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

NCT02962401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-29

No results posted yet for this study

Summary

Prospective national multicenter open label phase II Remodel WM3 trial

Conditions

Interventions

DRUG

Obinutuzumab

6 cycles every 28 days Cycle 1 :Obinutuzumab 1000mg I.V.(2 parts) 100mg day 1 and 900mg day 2 day 1, 8 and 15 Cycle 2 - 6 : Obinutuzumab 1000mg I.V.day 1

DRUG

Idelalisib

6 cycles every 28 days Cycle 1 : Idelalisib 150 mg x 2 p.o. day 1 to 28 Cycle 2 - 6 Idelalisib 150 mg x 2 p.o. day 1 to 28 Consolidation Idelalisib alone 150 mg twice a day until day 672 = 2 years after the beginning of the treatment

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Adeline LHERMITTE, Mrs · French Innovative Leukemia Organisation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2020-08-31
Completion
2023-04-13

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 NCT02962401 on ClinicalTrials.gov