Clinical trial NCT04895436: 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)
Official title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic Lymphocytic Leukemia (CLL)
Venetoclax
ABT-199
Venclexta
GDC-0199
Obinutuzumab
Gazyva
GA101
Cancer
ReVenG
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
First posted: 2021-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Primary outcomes:
measure: Overall response (OR) in Cohort 1 after end of combination treatment
timeFrame: 9 months
Secondary outcomes:
measure: OR in Cohort 1 after end of combination treatment
timeFrame: 9 months
measure: OR in Cohort 1 after end of treatment
timeFrame: 15 months
measure: Time to Response (TTR) in Cohort 1
timeFrame: 15 months
measure: Duration of Response (DOR) in Cohort 1
timeFrame: 15 months
measure: Time to Next Treatment (TTNT) for CLL in Cohort 1
timeFrame: 15 months
measure: Progression-free Survival (PFS) in Cohort 1
timeFrame: 15 months
measure: Overall Survival (OS) in Cohort 1
timeFrame: 15 months
measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
timeFrame: 9 months
measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment
timeFrame: 15 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 230157
state: California
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association /ID# 232606
state: Iowa
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 230061
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 230268
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital of Duluth /ID# 250021
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic /ID# 233443
state: Mississippi
city: Florham Park
country: United States
facility: Summit Medical Group-Florham Park /ID# 244782
state: New Jersey
city: Hackensack
country: United States
facility: Regional Cancer Care Associates /ID# 244620
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina /ID# 233313
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center /ID# 230201
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center /ID# 249533
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin-Madiso /ID# 232612
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 229898
state: South Australia
city: Epping
country: Australia
facility: Northern Hospital Epping /ID# 229847
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Ctr /ID# 254634
state: Victoria
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 243493
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz - Barmherzige Schwestern /ID# 249516
state: Oberoesterreich
city: Leoben
country: Austria
facility: Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 230013
state: Wien
city: Vienna
country: Austria
facility: Klinik Ottakring /ID# 230019
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 230010
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 243657
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Nove de Julho /ID# 243658
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi EAD /ID# 272321
city: Vratsa
country: Bulgaria
facility: MHAT Hristo Botev /ID# 229687
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend /ID# 230176
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 230164
state: Baden-Wuerttemberg
city: Landshut
country: Germany
facility: VK&K Studien GbR /ID# 230198
state: Bayern
city: Muenchen
country: Germany
facility: Muenchen Klinik Schwabing /ID# 230197
state: Bayern
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock /ID# 230190
state: Mecklenburg-Vorpommern
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln /ID# 230296
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes /ID# 248747
state: Saarland
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168
state: Sachsen-Anhalt
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis /ID# 245465
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748
city: Bremen
country: Germany
facility: Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 230181
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 245350
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH /ID# 230191
city: Landshut
country: Germany
facility: Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
city: Paderborn
country: Germany
facility: Bruederkrankenhaus St. Josef Paderborn /ID# 230177
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 243219
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 243218
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah /ID# 245059
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 243220
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
state: Piemonte
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni /ID# 229442
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute /ID# 241614
state: Bucuresti
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 229665
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital /ID# 267280
state: Lancashire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
state: Norfolk
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 250732
state: West Yorkshire
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: