OncRef

Clinical Trial: NCT03328104

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Emory University
Information Provided By:Emory University
Last Update Posted:2023-07-21

Study Overview

Brief 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.

Official Title

Aflac LL1602 ENCERT: A Phase 1 Trial Using Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Relapsed T Cell Lymphoblastic Leukemia/Lymphoma

Conditions

Lymphoblastic Leukemia, Lymphoblastic Lymphoma

Intervention / Treatment

  • Drug: Everolimus
  • Drug: Nelarabine
  • Drug: Cyclophosphamide
  • Drug: Etoposide

Other Study ID Numbers

  • IRB00095500

Start Date (Actual)

2018-07-24

Primary Completion Date (Actual)

2023-06-29

Study Completion Date (Actual)

2023-06-29

Enrollment (Actual)

8

Study Type

Interventional

Phase

Phase 1