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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, Obinutuzumab.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia (CLL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Brazil, Bulgaria +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Venetoclax
Oral tablet - Drug Obinutuzumab
Intravenous (IV) infusion
Primary outcome measures
- Overall response (OR) in Cohort 1 after end of combination treatment [Time frame: 9 months]
Secondary outcome measures (9)
- OR in Cohort 1 after end of combination treatment [Time frame: 9 months]
- OR in Cohort 1 after end of treatment [Time frame: 15 months]
- Time to Response (TTR) in Cohort 1 [Time frame: 15 months]
- Duration of Response (DOR) in Cohort 1 [Time frame: 15 months]
- Time to Next Treatment (TTNT) for CLL in Cohort 1 [Time frame: 15 months]
- Progression-free Survival (PFS) in Cohort 1 [Time frame: 15 months]
- Overall Survival (OS) in Cohort 1 [Time frame: 15 months]
- Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment [Time frame: 9 months]
- Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment [Time frame: 15 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 17 centers
- Stauferklinikum Schwaebisch Gmuend /ID# 230176 — Mutlangen
- Universitaetsklinikum Ulm /ID# 230164 — Ulm
- VK&K Studien GbR /ID# 230198 — Landshut
- Muenchen Klinik Schwabing /ID# 230197 — Munich
- Universitaetsmedizin Rostock /ID# 230190 — Rostock
- Universitaetsklinikum Koeln /ID# 230296 — Cologne
- Universitaetsklinikum des Saarlandes /ID# 248747 — Homburg
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168 — Dresden
- … and 9 more centers
United States · 15 centers
- Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla
- Winship Cancer Institute of Emory University /ID# 230643 — Atlanta
- Des Moines Oncology Research Association /ID# 232606 — Des Moines
- Dana-Farber Cancer Institute /ID# 230061 — Boston
- Henry Ford Hospital /ID# 230268 — Detroit
- St. Lukes Hospital of Duluth /ID# 250021 — Duluth
- Hattiesburg Clinic /ID# 233443 — Hattiesburg
- Summit Medical Group-Florham Park /ID# 244782 — Florham Park
- … and 7 more centers
Austria · 7 centers
- Universitaetsklinikum St. Poelten /ID# 243493 — Sankt Pölten
- Medizinische Universitaet Wien /ID# 230013 — Vienna
- Klinik Ottakring /ID# 230019 — Vienna
- Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 — Leoben
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 — Linz
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015 — Salzburg
- Hanusch Krankenhaus /ID# 230010 — Vienna
Israel · 4 centers
- Hadassah /ID# 245059 — Jerusalem
- The Chaim Sheba Medical Center /ID# 243219 — Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 243218 — Tel Aviv
- Rabin Medical Center. /ID# 243220 — Petah Tikva
Australia · 3 centers
- Royal Adelaide Hospital /ID# 229898 — Adelaide
- Northern Hospital Epping /ID# 229847 — Epping
- Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne
Brazil · 3 centers
- Hospital de Clinicas de Porto Alegre /ID# 243657 — Porto Alegre
- Hospital Nove de Julho /ID# 243658 — São Paulo
- Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659 — São Paulo
United Kingdom · 3 centers
- Blackpool Victoria Hospital /ID# 267280 — Blackpool
- Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733 — Norwich
- Leeds Teaching Hospitals NHS Trust /ID# 250732 — Leeds
Bulgaria · 2 centers
- UMHAT Sveti Georgi EAD /ID# 272321 — Plovdiv
- MHAT Hristo Botev /ID# 229687 — Vratsa
Italy · 2 centers
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504 — Turin
- Azienda Ospedaliera Santa Maria Terni /ID# 229442 — Terni
Romania · 1 center
- Fundeni Clinical Institute /ID# 241614 — Bucharest
Spain · 1 center
- Hospital Universitario de la Princesa /ID# 229665 — Madrid
Identifiers
NCT: NCT04895436 · M20-356 · 2023-504599-10-00