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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Camrelizumab and Decitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04510610

CHN-PLAGH-BT-056

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Camrelizumab plus decitabine

Experimental group

Description:

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

Treatment:

Drug: Camrelizumab and Decitabine