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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04510610
Other study ID # CHN-PLAGH-BT-056
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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