Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma

Phase 2

Recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Chidamide; Drug: Camrelizumab; Drug: Decitabine

• Registration Number: NCT04233294
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-02-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-14
• Primary Completion: 2024-02
• Study Completion: 2026-02

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 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.
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 one 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 (eg, infectious disease) illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chidamide in combination with camrelizumab plus decitabine	Chidamide	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
chidamide in combination with camrelizumab plus decitabine	Camrelizumab	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
chidamide in combination with camrelizumab plus decitabine	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

Primary Outcome Measures

Name	Time	Method
ORR	3 years	ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Adverse effects	3 years	Adverse effects were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

Trial Locations

Locations (1)

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