SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

Anti-PD-1 Antibody SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250962
• Other study ID #: CHN-PLAGH-BT-023
• Status: Recruiting
• Phase: Phase 2
• Start date: September 11, 2017
• Est. completion date: March 21, 2025

Study information

• Verified date: March 2019
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the above two groups), the stage II study will be revised to a multicohort, decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or refractory Hodgkin Lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 21, 2025
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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 four prior chemotherapy regimen, 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 with Anti-PD-1 antibody are eligible which must be resistance.

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 investigational product administration.

7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• SHR-1210
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
• Decitabine
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.

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stage I: Number of Subjects with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.	2 years
Primary	stage I: CRR assess by investigators per the 2014 Lugano classification	rate of subjects achieved complete response in all evaluable subjects	3 years
Primary	stage II: duration of CR	Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.	5 years
Secondary	stage II: 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
Secondary	stage II: Progression free survival	Time measured from the day of treatment to the date of first documented progression, or death from any cause.	5 years