An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02413489|
Recruitment Status : Terminated (DLBCL and FL cohorts met the pre-specified futility criteria and will not proceed. The MCL cohort was terminated due to slow recruitment and aggressive disease.)
First Posted : April 10, 2015
Results First Posted : June 26, 2018
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular||Drug: Daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, 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|
|Actual Study Start Date :||September 2, 2015|
|Actual Primary Completion Date :||June 1, 2017|
|Actual Study Completion Date :||June 1, 2017|
Participants will receive daratumumab (16 milligram per kilogram [mg/kg]) as intravenous infusion 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.
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.
- Overall Response Rate (ORR) [ Time Frame: After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years) ]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.
- Duration of Response [ Time Frame: Approximately 1.9 years ]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.
- Progression Free Survival (PFS) [ Time Frame: Approximately 1.9 years ]PFS was defined as the duration from the date of the first daratumumab dose to the date of progression or death, whichever comes first.
- Overall Survival (OS) [ Time Frame: Approximately 1.9 years ]Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death.
- Time to Response [ Time Frame: Approximately 1.9 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413489
|United States, California|
|Duarte, California, United States|
|Fountain Valley, California, United States|
|United States, Florida|
|Jacksonville, Florida, United States|
|Pembroke Pines, Florida, United States|
|United States, Georgia|
|Atlanta, Georgia, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Kentucky|
|Louisville, Kentucky, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States|
|United States, Nebraska|
|Omaha, Nebraska, United States|
|United States, New Jersey|
|New Brunswick, New Jersey, United States|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States|
|United States, Texas|
|Houston, Texas, United States|
|United States, Washington|
|Seattle, Washington, United States|
|Box Hill, Australia|
|Limoges Cedex, France|
|Nantes Cedex 01, France|
|Paris Cedex 10, France|
|Pierre Benite, France|
|Rouen Cedex, France|
|Korea, Republic of|
|Goyang-Si, Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|