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Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Primary Purpose

Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab and Decitabine
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
  • 2 12 to 75 years of age.
  • 3 ECOG performance of less than 2.
  • 4 Life expectancy of at least 3 months.
  • 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
  • 6 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.
  • 7 Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

  • 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  • 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
  • 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
  • 4 Prior organ allograft.
  • 5 Women who are pregnant or breastfeeding.
  • 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration.
  • 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Sites / Locations

  • Biotherapeutic Department and Hematology Department of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab plus decitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
August 11, 2020
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04510610
Brief Title
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Official Title
An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

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, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab plus decitabine
Arm Type
Experimental
Arm Description
Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab and 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. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
Primary Outcome Measure Information:
Title
duration of response
Description
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Time Frame
5 years
Title
Progression free survival
Description
Time measured from the day of treatment to the date of first documented progression, or death from any cause
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 2 12 to 75 years of age. 3 ECOG performance of less than 2. 4 Life expectancy of at least 3 months. 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. 6 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. 7 Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4 Prior organ allograft. 5 Women who are pregnant or breastfeeding. 6 Women with a positive pregnancy test on enrollment or prior to nvestigational product administration. 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Han, M.D.
Phone
+861055499341
Email
hanwdrsw@sina.com
Facility Information:
Facility Name
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han
Phone
86-10-13651392893
Email
hanwdrsw@sina.com

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

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