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Phase II Trial GA101 Inbrutinib B CLL

NCT02666898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-11-26

No results posted yet for this study

Summary

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months /

Study Part 1:

All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days

Study Part 2:

After evaluation at D1 of month 9:

If patients are in CR with BM MRD \< 10-4, they will continue ibrutinib alone at a dose of 420mg daily If patients have BM MRD \>10-4 whatever IWCLL 2008 responses or PR they will receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation of M16

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

DRUG

GA101

Part 1 :6 cycles Obinutuzumab/GA101: First cycle: D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v Cycle 2 to 6 (every 28 days) : D1 of every cycle: 1000 mg i.v PART 2 4 cycles -patients have BM MRD \>10-4 or PR: Cycle 1 to 4 Obitinuzumab/GA101: 1000 mg i.v on day 1

DRUG

Ibrutinib

Part 1 :6 cycles Cycle 2 to 6 (every 28 days) :Ibrutinib: D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2:4 cycles * patients in CR with BM MRD \< 10-4 : Ibrutinib alone 420mg daily * patients with BM MRD \>10-4 whatever responses or PR :Cycle 1 to 4 Ibrutinib 420mg daily with Cyclophosphamide and Fludarabine

DRUG

Cyclophosphamide

PART 2 : patients with BM MRD \>10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days Cyclophosphamide : 250 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and fludarabine

DRUG

Fludarabine

PART 2 : patients with BM MRD \>10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days : Fludarabine : 40 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and cyclophosphamide

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Valérie ROUILLE, Mrs · French Innovative Leukemia Organisation

  • Pierre FEUGIER, MD PD · French Innovative Leukemia Organisation

  • Anne Sophie MICHALLET, MD · 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
2015-10-31
Primary Completion
2017-05-31
Completion
2023-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT02666898 on ClinicalTrials.gov