Status:
UNKNOWN
Two Stage Study of Combination of Chemotherapy, SHR-1210 and/or Decitabine for Relapsed/Refractory PMBCLs
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Primary Mediastinal Large B-cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a two stage, Phase I/II clinical trial for patients with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL). In the first stage, the participants will receive GVD (Gemc...
Eligibility Criteria
Inclusion
- All patients had histologically proven PMBCL, and Radiographically measureable disease.
- Eastern Cooperative Oncology Group performance status 0-2
- Disease recurring within 6 months after first-line chemotherapy or disease progression while receiving or persistent disease after first-line chemotherapy
- Bulky disease was defined as the presence of a mediastinal mass \> 4.5 cm in axial diameter or extranodal lesion \> 3 cm.
- Subjects must have received at least two prior chemotherapy 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 with Anti-PD-1 antibody are eligible which must be resistance.
- Adequate organ function.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
- Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
Exclusion
- Known clinically active central nervous system involvement.
- Any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially
- Prior organ allograft.
- Receiving any other form of immunosuppressive medication, except steroid.
- Allogeneic hematopoietic stem cell transplantation within the last 5 years. 6） Known human immunodeficiency virus (HIV). 7） Has received a live vaccine within 30 days prior to first dose of study drug.
- 8） Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03346642
Start Date
May 1 2017
End Date
October 1 2019
Last Update
December 3 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853