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NANot yet recruitingPriority 4 · Lower priorityNCT07542912

Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This NA trial is evaluating SCA Induction followed by Response-Adapted Therapy as a treatment for people newly diagnosed with NK/T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

SCA Induction followed by Response-Adapted Therapy (DRUG): Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 \[SCA\]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen. Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin). Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy).

Drugs / treatments
SCA Induction followed by Response-Adapted Therapy
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
NA
Status
Not yet recruiting
Design
Non-randomized, open-label
Enrollment target
30 patients
Primary endpoint
Complete Remission rate
Ages
18 Years to —
Start date
2026-06-01
Est. completion
2029-06-01

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Sun Yat-sen University (OTHER)
Contact
Huiqiang Huang, Ph.D. | huanghq@sysucc.org.cn | 020-87343009

Tags

ENKTLMaintenanceNewly diagnosed
TrialCompass — Clinical Trial Summary

Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma

NCT07542912

Phase: NA | Status: Not yet recruiting | Priority: Lower

Plain-language summary

This NA trial is evaluating SCA Induction followed by Response-Adapted Therapy as a treatment for people newly diagnosed with NK/T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

Who can join

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

SCA Induction followed by Response-Adapted Therapy (DRUG): Drug: Sintilimab, Chidamide, and Azacitidine (SCA Regimen) Safety Lead-in: Patients receive Sintilimab (fixed dose) and Chidamide (fixed dose) combined with Azacitidine at two dose levels (100mg/d on days 1-3 vs. days 1-5) to verify the combination dose. Induction Phase: All enrolled patients receive 2 cycles of SCA induction: Sintilimab (200mg, D1), Chidamide (30mg, biw, D1-21), and Azacitidine (100mg, D1-3/5 \[SCA\]). Cycle length is 21 days. Response-Adapted Consolidation: Patients achieving Complete Response (CR) or Partial Response (PR) continue with 4 cycles of the SCA regimen. Patients with Stable Disease (SD) or Progressive Disease (PD) switch to 4 cycles of P-GemOx chemotherapy (Pemetrexed + Gemcitabine + Oxaliplatin). Radiation: Involved-Field Radiotherapy (IFRT) Following the completion of immunotherapy or chemotherapy, all patients receive local radiotherapy (≥50Gy).

Drugs / treatments: SCA Induction followed by Response-Adapted Therapy

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 30 patients

Primary endpoint: Complete Remission rate

Ages: 18 Years to —

Start date: 2026-06-01 | Est. completion: 2029-06-01

Locations

0 US sites · 1 total

Contact

Huiqiang Huang, Ph.D. | huanghq@sysucc.org.cn | 020-87343009

Sponsor: Sun Yat-sen University (OTHER)

Tags

ENKTL · Maintenance · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07542912

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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