Chronic Lymphocytic Leucemia Clinical Trial
Official title:
A Prospective, Multicenter, Phase-II Trial Evaluating Efficacy and Safety of Bendamustine + GA101 (BG) in Patients With Relapsed CLL Followed by Maintenance Therapy With GA101 for Responding Patients
A Prospective, Multicenter, Randomized Phase-Ii Trial Comparing Efficacy And Safety Of Fludarabine + Cyclophosphamide + Ga101 (Fcg) And Bendamustine + Ga101 (Bg) In Patients With Relapsed Or Refractory Cll Followed By Maintenance Therapy With Ga101 For Responding Patients
The type II anti-CD20 antibody GA101 has demonstrated a high efficacy as single agent (ORR
62%) and was well tolerated in previously treated patients with CLL.
Additionally, there is evidence that immunochemotherapy consisting of fludarabine,
cyclophosphamide and rituximab (FCR) is active in patients with refractory and relapsed CLL.
Besides FCR, the combination of bendamustine with rituximab (BR) has shown to be active in
both relapsed and previously untreated patients with CLL.
In preclinical studies GA101, a glycoengineered, humanized type II anti-CD20 antibody, has
shown superior activity compared with type I antibodies.
Therefore, a combination therapy with FC + GA101 (FCG) or B + GA101 (BG) might further
improve the therapeutic outcome in relapsed or refractory CLL. The CLLR3 trial was designed
to investigate and to compare the efficacy and safety of induction with both
immunochemotherapies followed additionally by a maintenance therapy with GA101 for responding
patients.
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Status | Clinical Trial | Phase | |
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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 | |
Completed |
NCT02345863 -
Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients
|
Phase 2 |