drugset
drugset / Trial / NCT06210750

Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)

NCT06210750 ↗

Phase 2 Withdrawn National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial tests the safety and effectiveness of giving chemotherapy with or without venetoclax and/or navitoclax for the treatment of patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax and navitoclax are in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. They may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving chemotherapy with or without venetoclax and/or navitoclax may be effective treatments for patients with newly diagnosed T-ALL or T-LBL.

Timeline

Start
2024-08-09
Primary completion
2026-09-22
Completion
2026-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Navitoclax Small molecule — Oral
Subject Venetoclax Small molecule — Oral
Background Calaspargase Pegol Protein / enzyme biologic — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Cytarabine Small molecule — Intrathecal
Background Daunorubicin Small molecule — Intravenous
Background Dexamethasone Small molecule — Oral
Background Doxorubicin Other / unclassified — Intravenous
Background MERCAPTOPURINE ANHYDROUS Small molecule — Oral
Background Methotrexate Small molecule — Intrathecal
Background Nelarabine Small molecule — Intravenous
Background Pegaspargase Protein / enzyme biologic — Intravenous
Background Thioguanine Small molecule — Oral
Background Vincristine Small molecule — Intravenous

Indications

T-cell acute lymphoblastic leukemia T-lymphoblastic lymphoma