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NCT04939272
Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Phase 1, PHASE2 trial testing Copanlisib Hydrochloride in Recurrent Mantle Cell Lymphoma in 8 participants. Participants enrolled and being followed up; not accepting new ones.
24 February 2026
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 29 June 2022 |
| Primary completion | 24 February 2026 |
| Estimated completion | 24 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Copanlisib Hydrochloride — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
- Recurrent Mantle Cell Lymphoma — all drugs for Recurrent Mantle Cell Lymphoma →
- Refractory Mantle Cell Lymphoma — all drugs for Refractory Mantle Cell Lymphoma →
Sponsor
City of Hope Medical Center
Who can join
18 and older, any sex, with Recurrent Mantle Cell Lymphoma or Refractory Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I/II trial studies the side effects, best dose, and effectiveness of copanlisib and venetoclax in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving copanlisib and venetoclax may help treat patients with mantle cell lymphoma.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Small-molecule agents for cancer immunotherapy.
Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010 -
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 -
Molecular Targeting of the Phosphoinositide-3-Protein Kinase (PI3K) Pathway across Various Cancers.
Shan KS, Bonano-Rios A, Theik NWY, Hussein A, et al · · 2024 · cited 19× · PMID 38396649 · DOI 10.3390/ijms25041973 -
Tipping the balance: toward rational combination therapies to overcome venetoclax resistance in mantle cell lymphoma.
Thus YJ, Eldering E, Kater AP, Spaargaren M. · · 2022 · cited 17× · PMID 35725771 · DOI 10.1038/s41375-022-01627-9 -
Metabolic Reprogramming and Potential Therapeutic Targets in Lymphoma.
Pang Y, Lu T, Xu-Monette ZY, Young KH. · · 2023 · cited 16× · PMID 36982568 · DOI 10.3390/ijms24065493 -
The shifting therapeutic paradigm for relapsed/refractory mantle cell lymphoma.
Arun Kumar S, Gao J, Patel SA. · · 2023 · cited 12× · PMID 37672954 · DOI 10.1016/j.leukres.2023.107385 -
Next-Generation Therapies in Mantle Cell Lymphoma (MCL): The Evolving Landscape in Treatment of Relapse/Refractory After CAR-T Cells.
Boccellato E, Comba L, Tavarozzi R, Castellino C, et al · · 2025 · cited 2× · PMID 40647536 · DOI 10.3390/cancers17132239
Verify or expand the search:
- PubMed search for NCT04939272
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Copanlisib Hydrochloride
Trials testing the same drug.
- NCT05295589 — Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum R · Phase 2 · withdrawn
- NCT04345913 — Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer · Phase 1, PHASE2 · active not recruiting
- NCT04317105 — Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimuma · Phase 1, PHASE2 · active not recruiting
- NCT03939897 — Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer · Phase 1 · active not recruiting
- NCT03484819 — Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma o · Phase 2 · completed
Other recruiting trials for Recurrent Mantle Cell Lymphoma
Currently open trials in the same condition.
- NCT07003295 — Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease R · Phase 2 · recruiting
- NCT06675123 — Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lym · Phase 1 · recruiting
- NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
- NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
- NCT06191887 — B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide · Phase 1 · recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04939272 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 1 May 2025
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