The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

Phase 2

Recruiting

• Conditions: Anti-PD-1 Antibody Resistant; Hodgkin Lymphoma
• Interventions: Drug: Chidamide; Decitabine; Camrelizumab; Drug: Decitabine+Camrelizumab

• Registration Number: NCT04514081
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-01
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-14
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-18
• Primary Completion: 2022-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. 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 investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chidamide+Decitabine+Camrelizumab	Chidamide; Decitabine; Camrelizumab	-
Decitabine+Camrelizumab	Decitabine+Camrelizumab	-

Primary Outcome Measures

Name	Time	Method
ORR assess by investigators per the 2014 Lugano classification	3 years	rate of subjects achieved objective response in all evaluable subjects
Number of Subjects with treatment-related adverse events (AEs)	3 years	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Biotherapeutic Department of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China