Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

Sponsor
Ou Bai, MD/PHD
Study ID
NCT05821192
Status
Unknown

Conditions

  • Angioimmunoblastic T-cell Lymphoma
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375mg/m2 by IV infusion once every 3 weeks
  • Gemcitabine — DRUG
    1 g/m2 on Days 1 by IV infusion once every 3 weeks
  • Dexamethasone — DRUG
    40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
  • Cisplatin — DRUG
    75 mg/m2 on Days 1 by IV infusion once every 3 weeks
  • PD-1 monoclonal antibody — DRUG
    200mg on Days 2 by IV infusion once every 3 weeks

Study Details

A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy.

Key Dates

Start date
Mar 23, 2023
Status verified
Apr 2023
Primary completion
Apr 18, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-GDP plus PD-1 monoclonal antibody
    Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 16 months ]

Central Contacts

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