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

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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