Copanlisib Plus Venetoclax in R/R DLBCL
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|ClinicalTrials.gov Identifier: NCT04572763|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
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:
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma||Drug: Copanlisib Drug: Venetoclax||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Copanlisib Plus Venetoclax for the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2025|
Experimental: Dose Escalation Copanlisib + Venetoclax
Other Name: Aliqopa
Tablet taken orally
Other Name: Venclexta
Experimental: Recommended phase II dose (RP2D) Copanlisib + Venetoclax
Patients will be treated with copanlisib in combination with venetoclax, administered at the Recommended phase II dose (RP2D).
Other Name: Aliqopa
Tablet taken orally
Other Name: Venclexta
- Maximum tolerated dose of venetoclax in combination with copanlisib (recommended phase II dose (RP2D) - Phase 1 [ Time Frame: 28 Days up to 1 year ]The highest dose of the drug combination that does not cause unacceptable side effects as assessed by protocol-specified DLT criteria.
- Overall response rate (ORR) - Phase II [ Time Frame: 28 Days ]Defined as the partial response (PR) and complete response (CR) rate, according to the Lugano criteria.
- Partial response Rate (PR) [ Time Frame: 28 Days ]Per Lugano criteria
- Complete response Rate (CR) [ Time Frame: 28 Days ]Per Lugano criteria
- Duration of response (DOR) [ Time Frame: Every 3 months to 1 year ]Legnth of time the patients respond to therapy
- Progression-free survival (PFS) [ Time Frame: Time from randomization (or registration) to the date of first documented progression or date of death from any cause, whichever comes first, for up to 5 years. ]The time from randomization (or registration) to progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
- Overall survival (OS) [ Time Frame: Time from randomization (or registration) to the date of death from any cause, assessed for up to 5 years. ]The time from randomization (or registration) to death due to any cause or censored at date last known alive.
- Exome sequencing [ Time Frame: Up to 1 year ]A genomic classifier will be applied to whole exome sequencing (WES) of DLBCL biopsy samples to determine genomic cluster.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572763
|Contact: Jennifer Crombie, MD||617-632-4106||Jennifer_Crombie@dfci.harvard.edu|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Contact: Jennifer Crombie, MD 617-632-4106 Jennifer_Crombie@dfci.harvard.edu|
|Principal Investigator: Jennifer Crombie, MD|
|Principal Investigator:||Jennifer Crombie, MD||Dana-Farber Cancer Institute|