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Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma

NCT06757387 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-01-03

No results posted yet for this study

Summary

This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

chidamide and golidocitinib

Enrolled patients will receive combination therapy with golidocitinib (150 mg QD or 150 mg QOD) and chidamide (20 mg BIW or 25 mg BIW)； If the MTD is determined at Dose Level 1 (chidamide 20 mg BIW / golidocitinib 150 mg QD), Dose Level 0 (chidamide 20 mg BIW / golidocitinib 150 mg QOD) will be further investigated. If the MTD is not established after escalating to Dose Level 2 (chidamide 25 mg BIW / golidocitinib 150 mg QD), the recommended Phase 2 dose (RP2D) will be determined through investigator consensus.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2028-12-30
Completion
2030-12-30

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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 NCT06757387 on ClinicalTrials.gov