Phase II Trial GA101 Inbrutinib B CLL

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT02666898
Phase
PHASE2
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GA101 — DRUG
    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
  • Ibrutinib — DRUG
    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
  • Cyclophosphamide — DRUG
    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
  • Fludarabine — DRUG
    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

Study Details

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

Key Dates

Start date
Oct 31, 2015
Status verified
Nov 2025
Primary completion
May 31, 2017
Completion
Sep 30, 2023

Study Design

Enrollment
135 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab and Ibrutinib CLL treatment
    3 parts PART 1: 6 cycles of GA101 + Ibrutinib 420mg PO/ 28 days: GA101: C 1 D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v C 2 to 6 :D1 1000 mg i.v Ibrutinib: D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2: 4 cycles / 28 days After evaluation at D1 month 9: * patients in CR with BM MRD \< 10-4, Ibrutinib 420mg daily * patients with BM MRD \>10-4 or PR 4 courses of GA101 + FC/ 28-day + Ibrutinib PO until M16 Cycle 1 to 4 - GA101: 1000 mg i.v on day 1 * Fludarabine : 40 mg/m² per os, days 2-4, / 28 days * Cyclophosphamide : 250 mg/m² per os, days 2-4, / 28 days * Ibrutinib 420mg/day PO PART 3 (only in GAI-FC+Ibru arm) : After evaluation at D1 of M16: * patients CR with BM MRD\< 10-4, treatment stopped * patients CR with BM MRD \>10-4, Ibrutinib continued until PD or PB MRD becomes negative.

Primary Outcome Measure

Study treatment response [ Time Frame: month 16 ]

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