Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550102
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Drug Response Profiling DRP Registry Zurich for Hematological Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Drug Response Profiling DRP Registry Zurich for Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRP_ZH
Brief Summary:
This study is a prospective non-randomized feasibility study of drug response profiling DRP in pediatric blood cancers Primary cancer cells are isolated from patients and screened ex vivo at single-cell resolution using automated fluorescence microscopy Drug sensitivity fingerprints are integrated with genetic annotations to inform the treating physician about personalized treatment options The study aims to determine the practicability of real-time drug response profiling and its actionability in identifying patient-specific cancer dependencies in refractory disease settings
Detailed Description:
This observational study offers a platform to assess the drug sensitivity of primary leukemia cells ex vivo The cancer cells are co-cultured in multi-well plates with supporting mesenchymal stroma cells and exposed to a library of both conventional eg steroids vincristine asparaginase as well as targeted chemotherapeutic agents eg tyrosine kinase inhibitors proteasome inhibitors B-cell lymphoma 2 BCL2 inhibitors Cells are imaged in parallel by high-content microscopy and subsequently segmented and classified by morphology and surface antigen expression Cell viability is quantified relative to dimethyl sulfoxide DMSO and as a function of drug concentration From the measured cell counts drug-specific sensitivity parameters eg half-maximal inhibitory concentration IC50 maximal inhibition Imax area under the curve AUC and their z-scores across the patient cohorts are calculated Drug response profiles are correlated to clinical response after a steroid pre-phase at day 8 and multiple minimal residual disease MRD timepoints measured by flow cytometry FCM or polymerase chain reaction PCR as defined by the trial protocol Data on clinical response to treatment and outcome will be enquired from the treating physician These include the disease stage initial diagnosis 1st relapse 2nd relapse and time point of sample collection the clinical trial and treatment arm the patient is enrolled in andor any individualized drug treatments Functional profiling data will be integrated with information about genetic lesions eg tumor protein TP53 subtype-defining translocations such as the Philadelphia chromosome t922q34q11 and surface antigen expression eg clusters of differentiation CD7192233117 Cytogenetics and molecular profiling data are collected from the treating clinics in collaboration with the international relapsed acute lymphoblastic leukemia IntReALL study group and the international Berlin-Frankfurt-Münster IBFM network
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None