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

Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510610
• Other study ID #: CHN-PLAGH-BT-056
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2020
• Source: Chinese PLA General Hospital
• Contact: Weidong Han, M.D.
• Phone: +861055499341
• Email: hanwdrsw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 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 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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital	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	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
Primary	Progression free survival	Time measured from the day of treatment to the date of first documented progression, or death from any cause	5 years