NCT04233294

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 2, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

January 15, 2020

Last Update Submit

August 12, 2020

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • ORR

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

    3 years

  • Adverse effects

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

    3 years

Study Arms (1)

chidamide in combination with camrelizumab plus decitabine

EXPERIMENTAL

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

Drug: ChidamideDrug: CamrelizumabDrug: Decitabine

Interventions

ChidamideDRUG

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.

chidamide in combination with camrelizumab plus decitabine
CamrelizumabDRUG

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

chidamide in combination with camrelizumab plus decitabine
DecitabineDRUG

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.

chidamide in combination with camrelizumab plus decitabine

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • Nie J, Wang C, Zheng L, Liu Y, Wang C, Chang Y, Hu Y, Guo B, Pan Y, Yang Q, Hu X, Han W. Epigenetic agents plus anti-PD-1 reprogram the tumor microenvironment and restore antitumor efficacy in Hodgkin lymphoma. Blood. 2024 Oct 31;144(18):1936-1950. doi: 10.1182/blood.2024024487.

    PMID: 39093981DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamidecamrelizumabDecitabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

February 2, 2020

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

CN(1)