9 results
The primary hypothesis of this study is that ibrutinib compared with temsirolimus significantly prolongs PFS in subjects with relapsed or refractory MCL who have received at least 1 prior rituximab-containing chemotherapy regimen.
1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10.This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
Primary ObjectiveThe primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.Secondary…
Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic [PK] and, if applicable,pharmacodynamic data) for use in pediatric subjects (age >=1 to <12 years)…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
PRIMARY: Dose finding part (Phase 1):To assess the safety and tolerability of durvalumab when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab to determine the recommended Phase 2 doses (RP2Ds) of each…