Actively Recruiting
Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2022-09-23
50
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
CONDITIONS
Official Title
Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Histologically confirmed diagnosis of DLBCL or related lymphoma types according to REAL/WHO classification
- Evidence of histological transformation to DLBCL from earlier low-grade lymphoma with subsequent relapse
- Received at least one and no more than three previous systemic treatments for DLBCL, including at least one CD20-targeted therapy
- Meet specified laboratory criteria at screening
- Use an effective barrier method of contraception
- Able and willing to receive prevention and treatment for blood clots and comply with pregnancy prevention risk management plan
You will not qualify if you...
- Other histological types of lymphoma, primary refractory DLBCL, or history of "double/triple hit" genetics
- Within 14 days before treatment start, have not discontinued prior CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy
- Underwent major surgery or significant traumatic injury within 14 days prior to treatment start
- Received live vaccines within 14 days before treatment start
- Require intravenous antimicrobial therapy for active infections within 14 days before treatment start
- Previously treated with CD19-targeted therapy or immunomodulatory drugs like thalidomide or lenalidomide
- Underwent autologous stem cell transplant within 3 months prior to consent
- Previous allogeneic stem cell transplant
- History of deep vein thrombosis or embolism without willingness or ability to take blood clot prevention during treatment
- Concurrent use of other anticancer or experimental treatments
- Prior history of cancers other than DLBCL
- Positive hepatitis B or C serology
- Known HIV infection or history of active infection
- Central nervous system lymphoma involvement
- Significant cardiovascular, central nervous system, or other systemic diseases affecting consent ability
- Severe liver impairment with total bilirubin over 3 mg/dL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Afflicated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
Huili Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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