Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial

Who is this study for? Child to adult patients with Relapsed or Refractory Hodgkin's Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
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• Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).

• 12 to 75 years of age.

• ECOG performance of less than 2.

• Life expectancy of at least 3 months.

• Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.

• Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.

• Subjects must have adequate marrow, live, renal and heart functions.

Locations
Other Locations
China
Biotherapeutic Department of Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2020-02-02
Estimated Completion Date: 2026-02
Participants
Target number of participants: 100
Treatments
Experimental: chidamide in combination with camrelizumab plus decitabine
chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov

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