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NCT04849715: CITADEL-310
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
Withdrawn
Phase 3
Last updated 29 April 2022
What this trial tests
Phase 3 trial testing parsaclisib in Mantle Cell Lymphoma. Withdrawn.
Timeline
11 March 2022
Primary endpoint
15 August 2030
15 August 2030
7 July 2034
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 11 March 2022 |
| Primary completion | 15 August 2030 |
| Estimated completion | 7 July 2034 |
Drugs / interventions tested
- parsaclisib — full drug profile →
- rituximab — full drug profile →
- bendamustine (BENDAMUSTINE) — full drug profile →
- Placebo
Conditions studied
- Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →
Sponsor
Incyte Corporation — full company profile →
Who can join
18 and older, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2 -
PI3K Inhibitors in Hematology: When One Door Closes….
Skånland SS, Okkenhaug K, Davids MS. · · 2024 · cited 19× · PMID 38967552 · DOI 10.1158/1078-0432.ccr-24-0967 -
Inhibitors of the PI3K/AKT/mTOR pathway in human malignancies; trend of current clinical trials.
Davoodi-Moghaddam Z, Jafari-Raddani F, Delshad M, Pourbagheri-Sigaroodi A, et al · · 2023 · cited 14× · PMID 37594532 · DOI 10.1007/s00432-023-05277-x -
mTOR hyperactivity and <i>RICTOR</i> amplification as targets for personalized treatments in malignancies.
Sztankovics D, Moldvai D, Petővári G, Dankó T, et al · · 2024 · cited 4× · PMID 38515456 · DOI 10.3389/pore.2024.1611643
Verify or expand the search:
- PubMed search for NCT04849715
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of parsaclisib
Trials testing the same drug.
- NCT05867030 — Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma · Phase 1 · withdrawn
- NCT04796922 — To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and · Phase 3 · withdrawn
- NCT04809467 — A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non · Phase 1, PHASE2 · terminated
- NCT04551053 — To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Re · Phase 3 · terminated
- NCT04551066 — To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) · Phase 3 · terminated
Other recruiting trials for Mantle Cell Lymphoma
Currently open trials in the same condition.
- NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
- NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
- NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
- NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
- NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
- NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04849715 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Incyte Corporation
- Last refreshed: 29 April 2022
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/NCT04849715.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing