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

Primary Purpose

Hodgkin Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide

Camrelizumab

Decitabine

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
12 to 75 years of age.
ECOG performance of less than 2.
Life expectancy of at least 3 months.
Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
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.
Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
Prior organ allograft.
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test on enrollment or prior to investigational product administration.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Sites / Locations

Biotherapeutic Department of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chidamide in combination with camrelizumab plus decitabine

Arm Description

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

Outcomes

Primary Outcome Measures

ORR

ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects

Adverse effects

Adverse effects were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

Secondary Outcome Measures

Full Information

NCT ID

NCT04233294

First Posted

January 15, 2020

Last Updated

August 12, 2020

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04233294

Brief Title

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

Official Title

Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2020 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chidamide in combination with camrelizumab plus decitabine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chidamide

Intervention Description

Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Intervention Description

Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Intervention Type

Drug

Intervention Name(s)

Decitabine

Intervention Description

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.

Primary Outcome Measure Information:

Title

ORR

Description

ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects

Time Frame

3 years

Title

Adverse effects

Description

Adverse effects were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 12 to 75 years of age. ECOG performance of less than 2. Life expectancy of at least 3 months. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. 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. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month . Prior organ allograft. Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to investigational product administration. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Facility Information:

Facility Name

Biotherapeutic Department of Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact: