The purpose of this study is to assess overall response rate \[ORR, including complete response (CR) and partial response (PR)\], of daratumumab in participants with non-Hodgkin's lymphoma \[a cancer of the lymph nodes (or tissues)-NHL\] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
This is an open label (everyone knows the study intervention), Phase 2 study to evaluate efficacy and safety of daratumumab in relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. The study will have three phases. Screening phase, treatment phase, follow-up phase. Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion approximately 3.5 years. Participants will primarily be assessed for overall response rate. Safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Daratumumab 16 mg/kg will be administered as intravenous infusion to participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.
Unnamed facility
Duarte, California, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Omaha, Nebraska, United States
...and 25 more locations
Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a greater than (\>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.
Time frame: After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years)
Duration of Response
Duration of response was the duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD). PD is defined as any new lesion \>1.5 centimeter (cm) in any axis or greater than or equal to (\>=) 50% increase in previously involved sites.
Time frame: Approximately 1.9 years
Progression Free Survival (PFS)
PFS was defined as the duration from the date of the first daratumumab dose to the date of progression or death, whichever comes first.
Time frame: Approximately 1.9 years
Overall Survival (OS)
Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death.
Time frame: Approximately 1.9 years
Time to Response
Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented.
Time frame: Approximately 1.9 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.