24 results
The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…
The objective of the study is to diminish the amount of chemotherapy and/ or radiotherapy for children with Hodgkin lymphoma who are likely to receive too much treatment with current treatment protocols.
Primary Objective* To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin*s Lymphoma (cHL).Secondary Objectives* To evaluate…
To determine appropriate dosing regimens for use in future clinical trials of GS 9820 in subjects with lymphoid malignancies.
1º Is there a significant difference of more than 10% in the pharmacokinetic parameter AUC of the investigated antineoplastic drugs (as a surrogate parameter for the efficacy) in the presence and absence of NNRTIs and/or PIs?2º Are there clinically…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
To evaluate whether chemotherapy alone is as effective -but less toxic-, as combined modality treatment in terms of progression-free survival (PFS), in patients with stages I/II Hodgkin*s lymphoma who are FDG-PET scan negative after two cycles of…
In the third follow-up we will include both factory A and B. The mayor strength is the increase in power by addition of approximately 15 years of follow-up. We will investigate the association between exposure and mortality, cancer mortality and…
Primary objectives:(1) To determine the safety and tolerability of pembrolizumab. (2) To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (…
PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…
Main objective:1. To estimate the Overall Response Rate (ORR) and the clinical benefit rate in selected cohorts of patients with hematologic malignancies,separately for each cohort2. To evaluate the safety of the selected dose regimes in an expanded…
This study has been transitioned to CTIS with ID 2023-504821-38-00 check the CTIS register for the current data. Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term…
The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL previously treated with an anti-PD1 antibody. Primary objective of the trial is to show efficacy of the experimental treatment strategy.Secondary…
Primary objective:To improve the PET negativity after two cycles of immuno-chemotherapyPrimary efficacy endpoint:PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.…
This study has been transitioned to CTIS with ID 2023-503715-14-00 check the CTIS register for the current data. Part A: To characterize the safety, tolerability, and define the MTD or RP2D for the combination of relatlimab + nivolumab in pediatric…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
This study has been transitioned to CTIS with ID 2024-518022-33-00 check the CTIS register for the current data. primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated…
The main research question is whether or not the administration of nivolumab increases "overall response rate" (ORR) in patients with classical Hodgkin Lymphoma who have progressed or relapsed following autologous stem cell transplant (…
Safety ObjectiveThe safety objective for this study is as follows:* To evaluate the safety and tolerability of atezolizumab in pediatric and young adult patients, focusing on the nature, frequency, and severity of serious and non-serious adverse…
Primary Objective part A:* To evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered BIW in subjects withadvanced solid tumors* To determine the MTD and/or RP2D of single-agent M4344 administered BIW in…