The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    200
  • sponsor
    Chinese PLA General Hospital
Updated on 24 January 2021
lymphoma
cell transplantation
classical hodgkin lymphoma
refractory hodgkin lymphoma

Summary

This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.

Details
Condition Hodgkin's Disease, Lymphoma, Anti-PD-1 Antibody Resistant, Anti-PD-1 Antibody Resistant, Anti-PD-1 Antibody Resistant, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, Anti-PD-1 Antibody Resistant
Treatment Chidamide; Decitabine; Camrelizumab, Decitabine+Camrelizumab
Clinical Study IdentifierNCT04514081
SponsorChinese PLA General Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 12 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Anti-PD-1 Antibody Resistant or Hodgkin's Disease or Lymphoma?
Do you have any of these conditions: hodgkin or Anti-PD-1 Antibody Resistant or hodgkin's lymphomas or hodgkins lymphoma or hodgkin lymphomas or hodgkin's lymphoma or Hodgkin's Disease or...?
Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL)
12 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 Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. 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

Exclusion Criteria

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 investigational product administration
Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
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