A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

Sponsor
Ruijin Hospital
Study ID
NCT05559008
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine Injection — DRUG
    Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
  • Dasatinib — DRUG
    Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
  • Linperlisib — DRUG
    Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
  • Tucidinostat — DRUG
    Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
  • SHR2554 — DRUG
    Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
  • Camrelizumab — DRUG
    Camrelizumab and Apatinib will be administered in T3.2 subtypes
  • Apatinib — DRUG
    Camrelizumab and Apatinib will be administered in T3.2 subtypes

Study Details

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.

Key Dates

First listed
Sep 29, 2022
Start date
Sep 30, 2022
Status verified
Nov 2022
Primary completion
Mar 26, 2024
Completion
Jan 26, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T1 subtypes based on next generation sequencing results
    T1 subtypes based on next generation sequencing results
  • Experimental: T2 subtypes based on next generation sequencing results
    T2 subtypes based on next generation sequencing results
  • Experimental: T3.1 subtypes based on next generation sequencing results
    T3.1 subtypes based on next generation sequencing results
  • Experimental: T3.2 subtypes based on next generation sequencing results
    T3.2 subtypes based on next generation sequencing results

Primary Outcome Measure

Overall response rate [ Time Frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days) ]

Central Contacts

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