Copanlisib Plus Venetoclax in R/R DLBCL
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ClinicalTrials.gov Identifier: NCT04572763 |
Recruitment Status :
Active, not recruiting
First Posted : October 1, 2020
Last Update Posted : October 11, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | September 22, 2020 | ||||||||||||||
First Posted Date ICMJE | October 1, 2020 | ||||||||||||||
Last Update Posted Date | October 11, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | September 8, 2021 | ||||||||||||||
Estimated Primary Completion Date | September 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Copanlisib Plus Venetoclax in R/R DLBCL | ||||||||||||||
Official Title ICMJE | A Phase I/II Study of Copanlisib Plus Venetoclax for the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma | ||||||||||||||
Brief Summary | This research study is evaluating the combination of two drugs, copanlisib and venetoclax, as a possible treatment for trelapsed/refractory diffuse large B-cell lymphoma (DLBCL) The names of the study drugs involved in this study are:
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Detailed Description | This study is an open-label, multi-center, non-randomized phase I/II study of the combination treatment copanlisib + venetoclax in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Phase I clinical trials test the safety of investigational drugs, and also try to define the appropriate dose of the investigational drugs to use for further studies. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease."Investigational" means that the drugs are being studied. Copanlisib is an IV medication that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior therapies. Venetoclax is an oral medication that is approved by the U.S. FDA for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and certain patients with acute myeloid leukemia (AML). The FDA has not approved copablisib or venetoclax for the treatment of DLBCL or the combination of copanlisib and venetoclax as a treatment for any disease. In the phase I portion of this study, the investigators are looking to determine the dose of venetoclax that is safe to give with copanlisib and to see what the side effects are of this combination. In the phase II trial, the investigators will be determining how effective venetoclax and copanlisib are for the treatment of R/R DLBCL. Data from laboratory suggest that some subsets of DLBCL are enriched for mutations that make them sensitive to the combination of copanlisib plus venetoclax. This study will look at genetic changes in your cancer and determine if abnormalities in specific genes make these drugs more or less effective. It is expected that about 48 people will take part in this research study. Bayer, a pharmaceutical company, is supporting this research study by providing the study drug copanlisib and funding for this study. Abbvie, a pharmaceutical company, is supporting this research study by providing the study drug venetoclax and funding for this study. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
48 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | September 1, 2025 | ||||||||||||||
Estimated Primary Completion Date | September 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04572763 | ||||||||||||||
Other Study ID Numbers ICMJE | 20-069 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Jennifer Crombie, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Jennifer Crombie, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | October 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |