Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
PIT565: Intravenous (i.v.) infusion or Subcutaneous (s.c.) injection
Study summary
This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
Eligibility
Primary outcome measure(s)
- Incidence and severity of Dose Limiting Toxicities (DLTs) — 28 days or 35 days, depending on the dosing schedule
Assessment of safety of study drug. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of CTCAE grade 3 or higher that occurs within the DLT evaluation period (28 days or 35 days depending on the schedule) and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with exceptions provided in the clinical protocol. - Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 21 months
Assessment of safety of study drug. - Frequency of dose interruptions — 21 months
Assessment of tolerability of study drug - Frequency of dose reductions — 21 months
Assessment of tolerability of study drug - Dose intensities — 21 months
Assessment of tolerability of study drug Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| University Of Miami | Miami | Florida | |
| University of Chicago Medical Center | Chicago | Illinois | |
| The University of Kansas Clinical Research Ctr | Fairway | Kansas | |
| Memorial Sloan Kettering Cancer Ctr | New York | New York | |
| Oregon Health Sciences University | Portland | Oregon | |
| Novartis Investigative Site | Ghent | Belgium | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Shanghai | China | |
| Novartis Investigative Site | Tianjin | China | |
| Novartis Investigative Site | Créteil | France | |
| Novartis Investigative Site | Marseille | France | |
| Novartis Investigative Site | Tel Aviv | Israel | |
| Novartis Investigative Site | Reggio Emilia | RE | |
| Novartis Investigative Site | Kashiwa | Chiba | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Barcelona | Spain | |
| Novartis Investigative Site | Barcelona | Spain |
More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05397496 on ClinicalTrials.gov ↗ ← All trials in Italy