NCT04572763

Copanlisib Plus Venetoclax in R/R DLBCL

Active, enrolled Phase 1, PHASE2 Last updated 7 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Copanlisib in Diffuse Large B Cell Lymphoma in 48 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 September 2021

Primary endpoint
29 July 2025

29 July 2026

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	8 September 2021
Primary completion	29 July 2025
Estimated completion	29 July 2026
Sites	3 locations across United States

Drugs / interventions tested

• Copanlisib (COPANLISIB) — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Diffuse Large B Cell Lymphoma — all drugs for Diffuse Large B Cell Lymphoma →
• Relapsed Diffuse Large B-Cell Lymphoma — all drugs for Relapsed Diffuse Large B-Cell Lymphoma →
• Refractory Diffuse Large B-Cell Lymphoma — all drugs for Refractory Diffuse Large B-Cell Lymphoma →

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Diffuse Large B Cell Lymphoma or Relapsed Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

* Copanlisib
* Venetoclax

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current State and Future Challenges for PI3K Inhibitors in Cancer Therapy.
   Sirico M, D'Angelo A, Gianni C, Casadei C, et al · · 2023 · cited 76× · PMID 36765661 · DOI 10.3390/cancers15030703
2. Molecular Genetics of Relapsed Diffuse Large B-Cell Lymphoma: Insight into Mechanisms of Therapy Resistance.
   Berendsen MR, Stevens WBC, van den Brand M, van Krieken JH, et al · · 2020 · cited 27× · PMID 33260693 · DOI 10.3390/cancers12123553
3. The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
   Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
4. Update on the role of copanlisib in hematologic malignancies.
   Le T, Jerel D, Bryan LJ. · · 2021 · cited 14× · PMID 33889376 · DOI 10.1177/20406207211006027
5. Translating the Biology of Diffuse Large B-cell Lymphoma Into Treatment.
   Danilov AV, Magagnoli M, Matasar MJ. · · 2022 · cited 10× · PMID 35305092 · DOI 10.1093/oncolo/oyab004
6. BCL-2 inhibitors in hematological malignancies: biomarkers that predict response and management strategies.
   Markouli M, Pagoni MN, Diamantopoulos P. · · 2024 · cited 2× · PMID 39906657 · DOI 10.3389/fonc.2024.1501950
7. 2026 Update on the Management of Diffuse Large B-Cell Lymphoma.
   Chong EA, Tomasulo EB, Barta SK. · · 2026 · PMID 41654318 · DOI 10.1002/ajh.70229
8. BCL-2 Family Inhibition Enhances mTORC1/2 Inhibition in PIK3CA-Mutant Colorectal Cancer.
   DeStefanis RA, Schmitz AE, Steimle AK, Payne SN, et al · · 2025 · PMID 40635161 · DOI 10.1158/1535-7163.mct-24-1096