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A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety,
Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib
Administered in Combination with Re-Induction Chemotherapy, and as a
Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML
Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years)
with FLT3-ITD mutations

This study has been transitioned to CTIS with ID 2023-510009-16-00 check the CTIS register for the current data. Primary Objectives:• Phase 1 Only: To determine the recommended Phase 2 dose(RP2D) of quizartinib, in combination with chemotherapy,…

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

An open-label study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of risdiplam (RO7034067) in adult and pediatric patients with spinal muscular atrophy

This study has been transitioned to CTIS with ID 2023-506739-14-00 check the CTIS register for the current data. Primary ObjectivesThe primary objectives of this study are as follows:• To evaluate the safety and tolerability of risdiplam.• To…

A phase II study evaluating the effect of DA-EPOCH-R induction followed by nivolumab consolidation in patients with newly diagnosed high grade B cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements

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…

A phase II study evaluating the feasibility and clinical efficacy of atezolizumab consolidation treatment in high risk diffuse large B-cell lymphoma

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…

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-504581-29-00 check the CTIS register for the current data. Primary* Part 1 (Dose Escalation): To characterize the safety of JNJ-64407564 and recommend thePhase 2 dose(s) and schedule* Part 2 (…

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

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…

A Phase 1/2 Study of the Oral TRK Inhibitor larotrectinib in Pediatric patients with Advanced Solid or Primary Central Nervous System Tumors

This study has been transitioned to CTIS with ID 2022-502668-20-00 check the CTIS register for the current data. PHASE 1 OBJECTIVES:Primary:To determine the safety of oral larotrectinib , including dose-limiting toxicity (DLT), in pediatric patients…

A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients
with Relapsed, Progressive or Refractory B-Cell Lymphoma

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*…

A Phase II single-arm trial to investigate tepotinib in advanced (locally advanced or metastatic) non-small cell lung cancer with MET exon 14 (METex14) skipping alterations or MET amplification (VISION)

This study has been transitioned to CTIS with ID 2024-512003-39-00 check the CTIS register for the current data. PART 1Cohort A (METex14 skipping alterations):• To assess the efficacy of tepotinib in subjects with locally advanced or metast. (NSCLC…

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy (CCTL019G2201J)

This study has been transitioned to CTIS with ID 2023-508081-15-00 check the CTIS register for the current data. Primary: - To evaluate the efficacy of tisagenlecleucel therapy as measured by the overall survival (OS)- To evaluate the efficacy of…

A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma

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…

Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN)

This study has been transitioned to CTIS with ID 2023-505376-30-00 check the CTIS register for the current data. The primary objective is to prospectively assess whether a sequential approach with an induction period of 12 weeks with encorafenib +…

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma.

This study has been transitioned to CTIS with ID 2023-503438-40-00 check the CTIS register for the current data. Primary: - Part 1 (Dose Escalation): To identify the recommended Phase 2 dose(s) and schedule assessed to be safe for teclistamab - Part…