B-cell Lymphoma
Conditions
Keywords
Relapsed Diffuse Large B-cell Lymphoma
Brief summary
A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL). * Stable disease or better for at least 3 months on most recent treatment * Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study * Adequate blood testing, liver, and kidney function as required by the study. * Eligible subjects will allow tissue samples to be examined and stored.
Exclusion criteria
* Patient has been treated with other investigational agents with a similar anti-tumor mechanism. * Patient should not have failed more than 3 prior treatment regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate based on FDG-PET and CT scan findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival. | — |
Outcome results
None listed