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)

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

— ReVenG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895436
• Other study ID #: M20-356
• Secondary ID: 2023-504599-10-0
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2022
• Est. completion date: January 28, 2029

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 28, 2029
• Est. primary completion date: February 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Venetoclax
Oral tablet
• Obinutuzumab
Intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	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
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015	Salzburg
Austria	Universitaetsklinikum St. Poelten /ID# 243493	Sankt Poelten	Niederoesterreich
Austria	Klinik Ottakring /ID# 230019	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 230013	Vienna	Wien
Austria	Hanusch Krankenhaus /ID# 230010	Wien
Brazil	Hospital de Clinicas de Porto Alegre /ID# 243657	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659	Sao Paulo
Brazil	Hospital Nove de Julho /ID# 243658	São Paulo	Sao Paulo
Bulgaria	MHAT Hristo Botev /ID# 229687	Vratsa
Germany	Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748	Berlin
Germany	Onkologische Schwerpunktpraxis /ID# 245465	Berlin
Germany	DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238	Bremen
Germany	Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168	Dresden	Sachsen-Anhalt
Germany	Universitaetsklinikum Essen /ID# 230181	Essen
Germany	Universitaetsklinikum Halle (Saale) /ID# 245350	Halle (Saale)
Germany	OncoResearch Lerchenfeld GmbH /ID# 230191	Hamburg
Germany	Universitaetsklinikum des Saarlandes /ID# 248747	Homburg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 230296	Köln	Nordrhein-Westfalen
Germany	Klinikum Landshut AdöR der Stadt Landshut /ID# 242991	Landshut
Germany	VK&K Studien GbR /ID# 230198	Landshut	Bayern
Germany	Muenchen Klinik Schwabing /ID# 230197	Muenchen
Germany	Stauferklinikum Schwaebisch Gmuend /ID# 230176	Mutlangen	Baden-Wuerttemberg
Germany	Bruederkrankenhaus St. Josef Paderborn /ID# 230177	Paderborn
Germany	Universitaetsmedizin Rostock /ID# 230190	Rostock	Mecklenburg-Vorpommern
Germany	Universitaetsklinikum Ulm /ID# 230164	Ulm	Baden-Wuerttemberg
Israel	Rabin Medical Center /ID# 243220	Haifa
Israel	Hadassah /ID# 245059	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 243219	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 243218	Tel Aviv	Tel-Aviv
Italy	Azienda Ospedaliera Santa Maria Terni /ID# 229442	Terni
Italy	AOU Citta della Salute e della Scienza di Torino /ID# 229504	Torino	Piemonte
Romania	Fundeni Clinical Institute /ID# 241614	Bucharest	Bucuresti
Spain	Hospital Universitario de la Princesa /ID# 229665	Madrid
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733	Norwich	Norfolk
United States	Dana-Farber Cancer Institute /ID# 230061	Boston	Massachusetts
United States	Novant Health Presbyterian Medical Center /ID# 230201	Charlotte	North Carolina
United States	Des Moines Oncology Research Association /ID# 232606	Des Moines	Iowa
United States	Henry Ford Health System /ID# 230268	Detroit	Michigan
United States	St. Luke's Hospital of Duluth /ID# 250021	Duluth	Minnesota
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	Moores Cancer Center at UC San Diego /ID# 230157	La Jolla	California
United States	University of Wisconsin-Madiso /ID# 232612	Madison	Wisconsin
United States	Novant Health Forsyth Medical Center /ID# 249533	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Bulgaria,  Germany,  Israel,  Italy,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response (OR) in Cohort 1 after end of combination treatment	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.	9 months
Secondary	OR in Cohort 1 after end of combination treatment	OR rate is defined as the percentage of participants achieving a best response of CR or CRi	9 months
Secondary	OR in Cohort 1 after end of treatment	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.	15 months
Secondary	Time to Response (TTR) in Cohort 1	TTR is defined as the time from first dose until first response (PR or better).	15 months
Secondary	Duration of Response (DOR) in Cohort 1	DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.	15 months
Secondary	Time to Next Treatment (TTNT) for CLL in Cohort 1	TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.	15 months
Secondary	Progression-free Survival (PFS) in Cohort 1	PFS is defined as the time from first dose until PD or death.	15 months
Secondary	Overall Survival (OS) in Cohort 1	OS is defined as the time from first dose until death.	15 months
Secondary	Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment	Percentage of participants with uMRD rate, measured in peripheral blood.	9 months
Secondary	Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment	Percentage of participants with uMRD rate, measured in peripheral blood.	15 months

External Links

•   Related info