Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
Recruiting
Phase 2
Interventional Study
Extranodal NK/T-cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 49 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Other
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About This Trial
This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PF…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center.
* Age between 18 and 75 years.
* At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenas…
Contacts