Phase II Trial GA101 Inbrutinib B CLL — ICLL07GAI  

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title: Phase II, Multicenter, Trial, Exploring "Chemo-free" Treatment (GA101+Ibrutinib) and MRD-driven Strategy in Previously Untreated Symptomatic B-chronic Lymphocytic Leukemia Medically Fit A Study From the Goelams/GCFLLC/MW Intergroup

Status Completed

Clinical Trial 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

Clinical Trial Description

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab during nine months followed by a MRD-driven strategy. Assessment of response as well as bone marrow MRD evaluation will be performed at Day 1 month 9:

1. Patients reaching CR with marrow MRD below 10-4 threshold will continue ibrutinib during 6 additional months.

2. Patients in PR or bone marrow MRD > 10-4 will receive Ibrutinib during 6 additional months and 4 courses of FC+ GA101. At Day 1 Month 16, patients in CR but with MRD> 10-4 will continue Ibrutinib until progressive disease.

3. Patients in stable or progressive disease will be excluded out of the trial.

Final evaluation of response (with BM MRD) will be performed at Day 1 Month 16. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

• NCT number: NCT02666898
• Study type: Interventional
• Source: French Innovative Leukemia Organisation
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Completion date: March 2018