Status:
COMPLETED
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Lead Sponsor:
Amgen
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.
Detailed Description
The study was planned as 2 parts: * Part 1 will test the safety of up to 3 different blinatumomab target dose levels in combination with pembrolizumab in a rolling 6 design. A Dose Level Review Team ...
Eligibility Criteria
Inclusion
- Have histologically confirmed diffuse large B-cell lymphoma that is either:
- Refractory after at least one regimen of systemic chemotherapy and/or targeted therapy, or
- In first or later relapse if have received at least 2 systemic regimens since time of diagnosis, or
- Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
- Have measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of ≥ 12 weeks in the opinion of the Investigator
- Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)
- Other Inclusion Criteria May Apply
Exclusion
- Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic leukemia) or primary mediastinal B cell lymphoma (PMBCL)
- History or presence of clinically relevant central nervous system pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol specified therapy.
- Has undergone prior allogeneic HSCT:
- within the last 5 years OR
- greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
- Has received autologous HSCT within 6 weeks prior to start of treatment.
- Other Exclusion Criteria May Apply.
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03340766
Start Date
March 16 2018
End Date
August 14 2023
Last Update
October 17 2024
Active Locations (22)
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1
Research Site
La Jolla, California, United States, 92093-0960
2
Research Site
Charleston, South Carolina, United States, 29424
3
Research Site
Greenville, South Carolina, United States, 29607
4
Research Site
Darlinghurst, New South Wales, Australia, 2010