NCT04582487

Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of identified compound.

Detailed description

This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. Genomic studies include karyotyping, CI-FISH and sequencing of 72 selected genes recurrently involved in T-ALL (by NGS). A panel of 80 compounds has been choosen for DSRP profile. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of compound hits. Meanwhile, in case of leukocytosis and uncontrolled disease, patients will be treated with cytoreductive therapies and best supportive care according to guidelines and scientific consensus. Every patient will receive a molecularly and functionally informed therapy following the therapeutic schedule already defined by in other tumors. Treatment will be selected on the basis of integration of genomic and small response data.

Conditions

• T Acute Lymphoblastic Leukemia
• Early T Acute Lymphoblastic Leukemia
• T-lymphoblastic Lymphoma
• Etp All

Interventions

Type	Name	Description
OTHER	bone marrow and/or peripheral blood samples withdrawal	bone marrow and/or peripheral blood samples evaluation

Timeline

• Start date: 2021-05-19
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2020-10-09
• Last updated: 2024-02-07

Locations

10 sites across 1 country: Italy