98 results
Primary ObjectivesCohorts 1, 2, 3, 4, and 5• Determine the efficacy, defined as overall response rate (ORR), of JCAR017 in subjects with aggressive B-cell non-Hodgkin lymphomaCohort 7• Evaluate the safety of JCAR017 treatment in subjects intended to…
The purposes of this trial are:• To find out the side effects (unexpected or unwanted reactions from taking a drug) when JNJ-64264681 and JNJ-67856633 are given in combination. • To find out how and at what dose(s) the combination of JNJ-64264681…
Run-in Part (Part 1)Objectives Primary* Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults Secondary* Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in…
Primary Objective- To determine if axicabtagene ciloleucel is superior to SOC as measured by event-free survival (EFS), as determined by blinded central reviewSecondary Objectives- To evaluate the effect of axicabtagene ciloleucel compared to SOC on…
This study has been transitioned to CTIS with ID 2022-501038-48-00 check the CTIS register for the current data. Primary objective:-To increase 12 months DFS of DH/TH-HGBL patients in CMR after DA-EPOCH-R from 70% to 85% with nivolumab consolidation…
This study has been transitioned to CTIS with ID 2022-501076-26-00 check the CTIS register for the current data. Primary objective:• To evaluate the 2-year disease free survival (DFS)Secondary objectives:• To evaluate toxicity and asses the relation…
This study has been transitioned to CTIS with ID 2023-508343-48-00 check the CTIS register for the current data. To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease…
This study has been transitioned to CTIS with ID 2023-504201-36-00 check the CTIS register for the current data. Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, lentiviral vectors), long-term…
Objective: Our main objective is to assess in detail risk factors for cardiovascular disease and cardiotoxicity and to compare heart function parameters, vascular parameters and biomarkers associated with cardiovascular function among 5- to 18-year…
This study has been transitioned to CTIS with ID 2023-504802-12-00 check the CTIS register for the current data. Dose Escalation Objectives:Primary:* Determine maximum tolerated dose (MTD) and RP2DSecondary:* Establish tolerability of epcoritamab*…
5. OBJECTIVES5.1. PRIMARY OBJECTIVESPhase III study:For the patients with advanced stage B-cell NHL/B-AL (stage III and LDH > Nx2, any stage IV or B-AL)to test whether adding 6 injections of rituximab to standard LMB chemotherapy regimen,…
This study has been transitioned to CTIS with ID 2023-508127-13-00 check the CTIS register for the current data. This single arm, multi-center, phase II study will determine the efficacy and safety of tisagenlecleucel in adult patients with FL who…
Currently, there are no curative treatment options for patients with Waldenstrom*s macroglobulinemia (WM) and there is no consensus on standard first line or relapse treatment. The proteasome inhibitor bortezomib has shown efficacy in WM, but is…
This study has been transitioned to CTIS with ID 2023-504994-19-00 check the CTIS register for the current data. This Phase II, open-label, multicenter study, will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with…
Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…
This study has been transitioned to CTIS with ID 2024-518422-32-01 check the CTIS register for the current data. Primary objectives: The first primary objective is to study the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-…
This study has been transitioned to CTIS with ID 2024-511235-10-00 check the CTIS register for the current data. To establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP + ibrutinib / R-DHAP followed by ASCT and…
Primary:- To determine the safety, tolerability, and dose-limiting toxicities (DLTs) of MCLA-145 and to determine an MTD and/or the RDE in advanced or metastatic solid tumors or B-cell lymphomas.Secondary:- To explore preliminary antitumor activity…
to determine the safety and efficacy of CTL019 in adults with relapsed or refractory DLBCL and to monitor all patients exposed to CTL019 for 5 years following CTL019 infusion
Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…