Status:
UNKNOWN
Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen
Lead Sponsor:
Han weidong
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
13-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which...
Eligibility Criteria
Inclusion
- Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 13 to 70 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 at least two prior chemotherapy regimen and four cycle of DP 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 must have adequate marrow, live, renal and heart functions.
Exclusion
- 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 (eg, infectious disease) illness.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04026269
Start Date
July 30 2019
End Date
December 31 2020
Last Update
July 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853