Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
- Registration Number
- NCT04510610
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 2 12 to 75 years of age.
- 3 ECOG performance of less than 2.
- 4 Life expectancy of at least 3 months.
- 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- 6 Subjects must have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- 7 Subjects must have adequate marrow, live, renal and heart functions.
Exclusion Criteria
- 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- 4 Prior organ allograft.
- 5 Women who are pregnant or breastfeeding.
- 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
- 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camrelizumab plus decitabine Camrelizumab and Decitabine Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
- Primary Outcome Measures
Name Time Method duration of response 5 years Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Progression free survival 5 years Time measured from the day of treatment to the date of first documented progression, or death from any cause
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
🇨🇳Beijing, China