Spots Global Cancer Trial Database for Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL
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 (Obinutuzumab), Acalabrutinib (ACP-196) and ABT-199 (Venetoclax) in Patients With Relapsed/Refractory CLL (CLL2-BAAG Protocol)
Study ID: NCT03787264
Conditions
Study Description
Brief Summary: CLL2-BAAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of debulking with bendamustine followed by induction and maintenance with GA101 (obinutuzumab), acalabrutinib (ACP-196) and venetoclax (ABT-199) in patients with relapsed/refractory CLL.
Detailed Description: In the CLL2-BAAG trial will be included a total of 46 patients with relapsed or refractory CLL in need of treatment.This trial will evaluate a debulking with two cycles bendamustine (only for patients with a higher tumor load), followed by an induction and a maintenance treatment with obinutuzumab, acalabrutinib and venetoclax in patients with re-lapsed/refractory CLL. The duration of maintenance treatment is depending on MRD levels. This trial combines one old (chemotherapy) and three novel, synergistic (antibody, BTK-inhibitor and Bcl-2 antagonist) principles of action in order to achieve deep and long lasting remissions with a short duration of treatment. Additionally, this trial has an extensive accompanying scientific program aiming at a better understanding of the kinetics of response and clonal evolution of CLL.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gemeinschaftspraxis Hämatologie Onkologie, Dresden, , Germany
Gemeinschaftspraxis Mohm/Prange-Krex, Dresden, , Germany
Universitatsklinik Carl Gustav Carus, Dresden, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Praxis fuer Haematologie und Onkologie, Koblenz, , Germany
Universitätsklinik Köln, Köln, , Germany
Gemeinschaftspraxis Haemato/ Onkologie Lebach, Lebach, , Germany
Klinikum Leverkusen GmbH, Leverkusen, , Germany
Krankenhaus Muenchen-Schwabing, Munich, , Germany
Ludwig-Maximilians-Universitaet Muenchen, München, , Germany
Praxis Dr. Uhlig, Naunhof, , Germany
Universitätsklinik Rostock, Rostock, , Germany
ZAHO-Rheinland, Siegburg, , Germany
Universitaetsklinik Tuebingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Contact Details
Name: Paula Cramer, Dr. med.
Affiliation: German CLL Study Group
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
