NCT04510610

Brief Summary

This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • duration of response

    Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.

    5 years

  • Progression free survival

    Time measured from the day of treatment to the date of first documented progression, or death from any cause

    5 years

Study Arms (1)

Camrelizumab plus decitabine

EXPERIMENTAL

Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.

Drug: Camrelizumab and Decitabine

Interventions

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

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 have received at least two lines of prior regimens without Anti-PD-1 antibody treatment history, and must be off therapy for at least 4 weeks prior to Day 1. 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 nvestigational 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 and Hematology Department of Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

camrelizumabDecitabine

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 12, 2020

Study Start

September 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2025

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

CN(1)