NCT02666898

Phase II Trial GA101 Inbrutinib B CLL

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 FILO Study. A Study From the Goelams/GCFLLC/MW Intergroup

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-05-01
• Completion: 2023-09-01
• First posted: 2016-01-28
• Last updated: 2025-11-26

Locations

1 site across 1 country: France