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NCT04659434
Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL
Phase 2 trial testing Sintilimab in Diffuse Large B Cell Lymphoma in 51 participants. Status unknown.
10 December 2022
Quick facts
| Lead sponsor | Qian Wenbin |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 10 December 2020 |
| Primary completion | 10 December 2022 |
| Estimated completion | 10 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — 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
Qian Wenbin
Who can join
Adults 18 to 80, 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 study evaluates the addition of Sintilimab to current 2nd line salvage therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation, patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and progression, death, intolerance and toxicity, withdrawal of informed consent, or other reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT will withdraw from this study and receive proper treatment based on investigator's decision.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04659434
- Europe PMC full search
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Related trials
Other trials of Sintilimab
Trials testing the same drug.
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- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
- NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
Other recruiting trials for Diffuse Large B Cell Lymphoma
Currently open trials in the same condition.
- NCT06687772 — CNS-Relapse Prevention in High-Risk Diffuse Large B-cell Lymphoma With Thiotepa-based Autologous Stem Cell Transplant · Phase 2 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06736613 — A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma · Phase 2 · recruiting
- NCT06552572 — Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy · Phase 2 · active not recruiting
- NCT06550141 — Emapalumab Prevention of CAR-T Cell Associated Toxicities · Phase 2 · recruiting
Other Qian Wenbin trials
Trials by the same sponsor.
- NCT07032324 — A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( C · Phase 1 · 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 NCT04659434 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Qian Wenbin
- Last refreshed: 9 December 2020
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/NCT04659434.
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