PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL

Sponsor
Sun Yat-sen University
Study ID
NCT04624984
Phase
PHASE2
Status
Unknown

Conditions

  • Classical Hodgkin Lymphoma
  • Refractory or Relapsed Classical Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy.

Key Dates

Start date
Apr 1, 2021
Status verified
May 2022
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

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

Arms

  • Experimental: PD-1 Inhibitor or PD-1 Inhibitor with GVD
    All patients receive PD-1 Inhibitor on day 1. Treatment cycles repeat every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR or PR receive PD-1 Inhibitor for another 3 cycles. Patients with PD or SD receive PD-1 Inhibitor plus GVD (gemcitabine, vinorelbine and doxorubicin liposome) regimen every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET/CT confirmed CR after 6 cycles of PD-1 Inhibitor treatment can receive radiotherapy or ASCT, which is determined by investigators. Patients with PR receive 2-4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with PD or SD receive 4 cycles of PD-1 Inhibitor plus GVD regimen. Patients with confirmed CR or PR after PD-1 Inhibitor plus GVD regimen can receive radiotherapy or ASCT, which is determined by investigators. Patients with PD or SD quit the trial.

Primary Outcome Measure

Complete remission rate [ Time Frame: 2 years ]

Central Contacts

Related Studies