Chronic Lymphocytic Leucemia Clinical Trial
Official title:
A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)
A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.
In the CLL2-BIG trial an allcomer CLL population with indication for treatment will be
included.
Patient will receive 2 cycles of debulking treatment with bendamustin unless
contraindications are existing or debulking is not indicated.
Afterwards 6 cycles of induction therapy with GA101 and ibrutinib will be applied, each with
a duration of 28 days. Primary endpoint overall Response rate will be assessed at final
restaging.
Patients benefitting from BIG treatment will enter the maintenance phase of the trial.
Maintenance treatment will be continued if no unacceptable toxicity occurs until three months
after negativity of minimal residual disease [MRD] is achieved in peripheral blood in
patients with (clinical) complete response (CR) or (clinical) incomplete complete response
[CRi] (confirmed by 2 consecutive testings of MRD within 3 months), progression of CLL, start
of a subsequent therapy or up to 8 cycles of maintenance (each cycle with a duration of 84
calendar days = 3 months), whichever occurs first.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02320383 -
CLLR3: Bendamustine + GA101 (BG) in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients
|
Phase 2 | |
Active, not recruiting |
NCT02401503 -
Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)
|
Phase 2 | |
Completed |
NCT02445131 -
Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)
|
Phase 2 |