The purpose of this study is to evaluate the safety, tolerability, dose-limiting
toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD),
recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when
administered intravenously to participants with relapsed or refractory B-cell
malignancies [diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL),
mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic
leukemia (ALL)].
Additional locations may be listed on ClinicalTrials.gov for NCT02454270.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Name Not Available
This first in human study consists of 2 parts: a) The dose escalation part and b) The
dose expansion part. This is an openlabel (all participants know the identity of the
intervention), multicenter (more than one study site) study to evaluate the safety,
establish a recommended Phase 2 dose (RP2D), and to determine the preliminary efficacy of
duvortuxizumab in participants with relapsed or refractory B cell malignancies. The dose
escalation part of the trial (Part 1) will be comprised of 3 different patient groups
based on disease indication: Group 1 (DLBCL, FL, MCL); Group 2 (CLL); Group 3 (ALL). The
duvortuxizumab dosing will be done on biweekly and weekly basis. Duvortuxizumab weekly
escalating dosing will be investigated. Dose escalation will begin with Group 1 and will
initially follow an accelerated dose titration design, followed by a traditional 3+3
design. At each dose escalation level the treatment of the second participant should be
initiated after at least 72 hours of observation after the start of the first
duvortuxizumab dose of the first participant. Dose escalation in Groups 2 and 3 will
follow a 3+3 design and will begin after the initial dose level in Group 1 is deemed
safe. Participants [Group 1 (DLBCL, FL, MCL), Group 2 (CLL) Group 3 (ALL)] are enrolled
into cohorts of increasing dose levels of duvortuxizumab administered in 28 day treatment
cycles. Up to 3 RP2Ds may be determined in Part 1 (one RP2D for Group 1, one RP2D for
Group 2, and one RP2D for Group 3). In the cohort expansion part of the trial (Part 2),
participants with relapsed or refractory B cell malignancies (DLBCL, FL, MCL, CLL and
ALL) will be enrolled according to tumor type in up to 5 cohorts and receive
duvortuxizumab at the RP2D determined in Part 1 for their disease type. The study
consists of 3 periods: Screening period (up to 28 days prior to the first dose of study
drug); Treatment period [first dose of study drug until the End of Treatment Visit
(within 30 days after the last dose)]; and follow up period [End of Treatment Visit and
continue until death, lost to follow up, consent withdrawal, or study end (as determined
by the sponsor), whichever occurs first]. Number of participants who achieve an overall
response in each Dose Expansion cohort will be evaluated primarily. Participants' safety
will be monitored throughout the study.
Lead OrganizationJanssen Pharmaceuticals
