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

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Hodgkin Lymphoma

Treatments

Drug: Camrelizumab and Decitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04510610
CHN-PLAGH-BT-056

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

12 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Camrelizumab plus decitabine
Experimental group
Description:
Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
Treatment:
Drug: Camrelizumab and Decitabine

Trial contacts and locations

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Central trial contact

Weidong Han, M.D.

Data sourced from clinicaltrials.gov

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