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NCT04803123
Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL
EARLY_PHASE1 trial testing Copanlisib in Leukemia, Acute Lymphocytic in 3 participants. Terminated before completion.
3 April 2023
Quick facts
| Lead sponsor | Dorothy Sipkins, MD, PhD |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 21 June 2021 |
| Primary completion | 3 April 2023 |
| Estimated completion | 26 April 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Copanlisib (COPANLISIB) — full drug profile →
Conditions studied
- Leukemia, Acute Lymphocytic — all drugs for Leukemia, Acute Lymphocytic →
Sponsor
Dorothy Sipkins, MD, PhD
Who can join
18 and older, any sex, with Leukemia, Acute Lymphocytic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will provide an evaluation of biologic markers of leukemia cell response following a single dose of copanlisib prior to any salvage induction therapy in a projected cohort of 10 relapsed/refractory B-ALL patients.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Leukaemia: a model metastatic disease.
Whiteley AE, Price TT, Cantelli G, Sipkins DA. · · 2021 · cited 139× · PMID 33953370 · DOI 10.1038/s41568-021-00355-z -
Central nervous system involvement in childhood acute lymphoblastic leukemia: challenges and solutions.
Thastrup M, Duguid A, Mirian C, Schmiegelow K, et al · · 2022 · cited 71× · PMID 36266325 · DOI 10.1038/s41375-022-01714-x -
How I prevent and treat central nervous system disease in adults with acute lymphoblastic leukemia.
Kopmar NE, Cassaday RD. · · 2023 · cited 38× · PMID 36548957 · DOI 10.1182/blood.2022017035 -
PI3K Targeting in Non-solid Cancer.
Kim HN, Ogana H, Sanchez V, Nichols C, et al · · 2022 · cited 5× · PMID 36243854 · DOI 10.1007/978-3-031-06566-8_17
Verify or expand the search:
- PubMed search for NCT04803123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Copanlisib
Trials testing the same drug.
- NCT05082025 — Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K · Phase 2 · terminated
- NCT04933617 — Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas · Phase 1 · terminated
- NCT05010096 — BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors · Phase 1 · withdrawn
- NCT04750941 — Study of Copanlisib and Ketogenic Diet · Phase 2 · terminated
- NCT04572763 — Copanlisib Plus Venetoclax in R/R DLBCL · Phase 1, PHASE2 · active not 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 NCT04803123 (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 Dorothy Sipkins, MD, PhD
- Last refreshed: 21 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04803123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing