Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Interventions
- Registration Number
- NCT04895436
- Lead Sponsor
- AbbVie
- Brief Summary
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed.
Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide.
Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
- Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
- More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.
- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 - venetoclax + obinutuzumab Obinutuzumab Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles. Cohort 1 - venetoclax + obinutuzumab Venetoclax Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles. Cohort 2 - venetoclax + obinutuzumab Venetoclax Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles. Cohort 2 - venetoclax + obinutuzumab Obinutuzumab Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
- Primary Outcome Measures
Name Time Method Overall response (OR) in Cohort 1 after end of combination treatment 9 months OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.
- Secondary Outcome Measures
Name Time Method Time to Next Treatment (TTNT) for CLL in Cohort 1 15 months TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
Progression-free Survival (PFS) in Cohort 1 15 months PFS is defined as the time from first dose until PD or death.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment 9 months Percentage of participants with uMRD rate, measured in peripheral blood.
OR in Cohort 1 after end of combination treatment 9 months OR rate is defined as the percentage of participants achieving a best response of CR or CRi
OR in Cohort 1 after end of treatment 15 months OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response.
Duration of Response (DOR) in Cohort 1 15 months DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
Overall Survival (OS) in Cohort 1 15 months OS is defined as the time from first dose until death.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment 15 months Percentage of participants with uMRD rate, measured in peripheral blood.
Time to Response (TTR) in Cohort 1 15 months TTR is defined as the time from first dose until first response (PR or better).
Trial Locations
- Locations (54)
UMHAT Sveti Georgi EAD /ID# 272321
🇧🇬Plovdiv, Bulgaria
Hanusch Krankenhaus /ID# 230010
🇦🇹Wien, Austria
OncoResearch Lerchenfeld GmbH /ID# 230191
🇩🇪Hamburg, Germany
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
🇩🇪Landshut, Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
🇩🇪Paderborn, Germany
The Chaim Sheba Medical Center /ID# 243219
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243218
🇮🇱Tel Aviv, Tel-Aviv, Israel
Hadassah /ID# 245059
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 243220
🇮🇱Petah Tikva, Israel
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
🇦🇹Linz, Oberoesterreich, Austria
Moores Cancer Center at UC San Diego /ID# 230157
🇺🇸La Jolla, California, United States
Des Moines Oncology Research Association /ID# 232606
🇺🇸Des Moines, Iowa, United States
Dana-Farber Cancer Institute /ID# 230061
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital /ID# 230268
🇺🇸Detroit, Michigan, United States
St. Luke's Hospital of Duluth /ID# 250021
🇺🇸Duluth, Minnesota, United States
Hattiesburg Clinic /ID# 233443
🇺🇸Hattiesburg, Mississippi, United States
Summit Medical Group-Florham Park /ID# 244782
🇺🇸Florham Park, New Jersey, United States
Regional Cancer Care Associates /ID# 244620
🇺🇸Hackensack, New Jersey, United States
Novant Health Presbyterian Medical Center /ID# 230201
🇺🇸Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 249533
🇺🇸Winston-Salem, North Carolina, United States
University of Wisconsin-Madiso /ID# 232612
🇺🇸Madison, Wisconsin, United States
Royal Adelaide Hospital /ID# 229898
🇦🇺Adelaide, South Australia, Australia
Northern Hospital Epping /ID# 229847
🇦🇺Epping, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 254634
🇦🇺Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 243493
🇦🇹Sankt Poelten, Niederoesterreich, Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
🇦🇹Leoben, Steiermark, Austria
Medizinische Universitaet Wien /ID# 230013
🇦🇹Vienna, Wien, Austria
Klinik Ottakring /ID# 230019
🇦🇹Vienna, Wien, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
🇦🇹Salzburg, Austria
Hospital Nove de Julho /ID# 243658
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
🇧🇷Sao Paulo, Brazil
Stauferklinikum Schwaebisch Gmuend /ID# 230176
🇩🇪Mutlangen, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm /ID# 230164
🇩🇪Ulm, Baden-Wuerttemberg, Germany
VK&K Studien GbR /ID# 230198
🇩🇪Landshut, Bayern, Germany
Muenchen Klinik Schwabing /ID# 230197
🇩🇪Muenchen, Bayern, Germany
Hospital de Clinicas de Porto Alegre /ID# 243657
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
MHAT Hristo Botev /ID# 229687
🇧🇬Vratsa, Bulgaria
Universitaetsmedizin Rostock /ID# 230190
🇩🇪Rostock, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Koeln /ID# 230296
🇩🇪Köln, Nordrhein-Westfalen, Germany
Universitaetsklinikum des Saarlandes /ID# 248747
🇩🇪Homburg, Saarland, Germany
Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168
🇩🇪Dresden, Sachsen-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
🇩🇪Kiel, Schleswig-Holstein, Germany
Onkologische Schwerpunktpraxis /ID# 245465
🇩🇪Berlin, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748
🇩🇪Berlin, Germany
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
🇩🇪Bremen, Germany
Universitaetsklinikum Essen /ID# 230181
🇩🇪Essen, Germany
Universitaetsklinikum Halle (Saale) /ID# 245350
🇩🇪Halle (Saale), Germany
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442
🇮🇹Terni, Italy
Fundeni Clinical Institute /ID# 241614
🇷🇴Bucharest, Bucuresti, Romania
Hospital Universitario de la Princesa /ID# 229665
🇪🇸Madrid, Spain
Blackpool Victoria Hospital /ID# 267280
🇬🇧Blackpool, Lancashire, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
🇬🇧Norwich, Norfolk, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 250732
🇬🇧Leeds, West Yorkshire, United Kingdom