NCT04514081

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 13, 2020

Last Update Submit

August 17, 2020

Conditions

Hodgkin LymphomaAnti-PD-1 Antibody Resistant

Outcome Measures

Primary Outcomes (2)

  • ORR assess by investigators per the 2014 Lugano classification

    rate of subjects achieved objective response in all evaluable subjects

    3 years

  • Number of Subjects with treatment-related adverse events (AEs)

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    3 years

Study Arms (2)

Chidamide+Decitabine+Camrelizumab

EXPERIMENTAL
Drug: Chidamide; Decitabine; Camrelizumab

Decitabine+Camrelizumab

ACTIVE COMPARATOR
Drug: Decitabine+Camrelizumab

Interventions

Chidamide; Decitabine; CamrelizumabDRUG

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

Chidamide+Decitabine+Camrelizumab
Decitabine+CamrelizumabDRUG

Decitabine+Camrelizumab

Decitabine+Camrelizumab

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 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.
  • 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 1 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 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

MeSH Terms

Conditions

Hodgkin Disease

Interventions

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

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

Central Study Contacts

Weidong Han, M.D.

CONTACT

+861055499341hanwdrsw@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 14, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2025

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

CN(1)