Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

NCT ID: NCT04510610

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-01-01

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab plus decitabine

Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.

Group Type: EXPERIMENTAL

Camrelizumab and Decitabine

Intervention Type: DRUG

Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Interventions

Camrelizumab and Decitabine

Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han weidong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Weidong Han, M.D.

Role: CONTACT

hanwdrsw@sina.com

+861055499341

Facility Contacts

Weidong Han

Role: primary

hanwdrsw@sina.com

86-10-13651392893

Other Identifiers

CHN-PLAGH-BT-056

Identifier Type: -

Identifier Source: org_study_id