Last reviewed · How we verify
NCT05322733
Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL
Phase 2 trial testing Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in 25 participants. Status unknown.
22 February 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 15 April 2022 |
| Primary completion | 22 February 2025 |
| Estimated completion | 5 November 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Orelabrutinib
- Obinutuzumab — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
Conditions studied
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma — all drugs for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
Adults 18 to 65, any sex, with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (oFCG) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
EHA2024 Hybrid Congress
· 2024 -
[Advances in clinical research on novel BTK inhibitors for the treatment of chronic lymphocytic leukemia].
Qiu TL, Miao Y, Li JY. · · 2023 · PMID 38185530 · DOI 10.3760/cma.j.issn.0253-2727.2023.11.015
Verify or expand the search:
- PubMed search for NCT05322733
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Orelabrutinib
Trials testing the same drug.
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- NCT07410520 — PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. · Phase 2 · recruiting
- NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
- NCT07499271 — Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation · Phase 2 · recruiting
- NCT07355699 — Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma · Phase 4 · recruiting
Other recruiting trials for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Currently open trials in the same condition.
- NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
- NCT06978088 — LP-168 and Obinutuzumab for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This · Phase 2 · recruiting
- NCT06757647 — Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma · Phase 2 · recruiting
- NCT05643235 — Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors · NA · recruiting
- NCT05294731 — Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Deg · Phase 1, PHASE2 · recruiting
Other The First Affiliated Hospital with Nanjing Medical University trials
Trials by the same sponsor.
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
- NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT05322733 (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 The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 19 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/NCT05322733.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing