Clinical Trials Logo

Clinical Trial Summary

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)].


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02454270
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Terminated
Phase Phase 1
Start date June 15, 2015
Completion date July 26, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03977623 - Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Recruiting NCT02428751 - R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma Phase 3
Completed NCT02555267 - Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma
Active, not recruiting NCT02364050 - Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM
Terminated NCT00529503 - A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL Phase 2
Terminated NCT02413489 - An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma Phase 2
Completed NCT02086604 - Brentuximab Vedotin and Lenalidomide for Relapsed or Refractory Diffuse Large B-cell Lymphoma Phase 1
Completed NCT01421524 - Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma Phase 1
Recruiting NCT03600363 - A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients Phase 2
Recruiting NCT03646422 - AEDV Registry of Primary Cutaneous Lymphoma
Recruiting NCT04446962 - LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV) Phase 1/Phase 2
Withdrawn NCT03241017 - Durvalumab in DLBCL After Autologous Transplant Phase 2
Recruiting NCT02928861 - 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma N/A
Recruiting NCT02931201 - Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Diffuse Large B-cell Lymphoma N/A
Terminated NCT02592876 - Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma Phase 2
Completed NCT00849147 - Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603) Phase 2
Completed NCT00822432 - Coproporphyrine Isomers and Methotrexate Elimination N/A
Completed NCT03682796 - Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma Phase 1
Recruiting NCT04982471 - Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Completed NCT03744676 - A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) Phase 2