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Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

NCT04052659 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-09

No results posted yet for this study

Summary

This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Sintilimab

200 mg IV, every 3 weeks, d1

DRUG

Chidamide

30 mg PO, 2 times every week, d1 and d4

DRUG

Azacidine

100 mg SC, every 3 weeks, d1 to d7

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Yuqin Song, Doctor · Cancer Hospital of Beijing University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052659 on ClinicalTrials.gov