NCT04337606

Brief Summary

This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.

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 P75+ for phase_1

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2026

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

April 4, 2020

Last Update Submit

April 4, 2020

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • CR rate

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

    2 years

  • Adverse events

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

    2 years

Study Arms (2)

chidamide in combination with decitabine

EXPERIMENTAL

chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks

Drug: ChidamideDrug: Decitabine

decitabine in combination with Camrelizumab

EXPERIMENTAL

decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6

Drug: DecitabineDrug: Camrelizumab

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; 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 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 decitabinedecitabine in combination with Camrelizumab
CamrelizumabDRUG

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

decitabine in combination with Camrelizumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.
  • to 65 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 new lesion \>1.5cm as defined by lymphoma response criteria.
  • Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.
  • 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

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 7, 2020

Study Start

April 4, 2020

Primary Completion

April 4, 2024

Study Completion

April 4, 2026

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

CN(1)