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UnknownNCT05821192

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

A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
34 (estimated)
Sponsor
Ou Bai, MD/PHD · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Objective to evaluate the efficacy and safety of R-GDP (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) plus PD-1 monoclonal antibody in patients with refractory or relapsed peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma.

Conditions

Interventions

TypeNameDescription
DRUGRituximab375mg/m2 by IV infusion once every 3 weeks
DRUGGemcitabine1 g/m2 on Days 1 by IV infusion once every 3 weeks
DRUGDexamethasone40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
DRUGCisplatin75 mg/m2 on Days 1 by IV infusion once every 3 weeks
DRUGPD-1 monoclonal antibody200mg on Days 2 by IV infusion once every 3 weeks

Timeline

Start date
2023-03-23
Primary completion
2023-04-18
Completion
2024-12-31
First posted
2023-04-20
Last updated
2023-04-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05821192. Inclusion in this directory is not an endorsement.