drugset / Trial / NCT03328104

Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma

NCT03328104

Phase 1 Completed 8 enrolled Emory University
NaSingle-groupOpen-labelTreatment

Summary

T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an increase in proteins in a specific pathway called the mTOR pathway within the cancer cells. In cancer cells it can encourage untimely cell growth, cell production, and cell survival. Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of cancer cells. It also prevents communication within cells and stops proteins from being made that may contribute to leukemia. The main purpose of the study is to find the maximum tolerated dose of everolimus when used together with standard chemotherapy.

Timeline

Start
2018-07-24
Primary completion
2023-06-29
Completion
2023-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 3 mg/m2 Oral
Subject Everolimus Small molecule 4 mg/m2 Oral
Subject Everolimus Small molecule 5 mg/m2 Oral
Background Cyclophosphamide Other / unclassified 440 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Nelarabine Small molecule 650 mg/m2 Intravenous