NCT03328104

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 2 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Two to six participants will receive the starting dose of everolimus. If the side effects are not too severe, the next group of participants will take the study drug at a higher dose level. Up to two dose levels of the study drug will be tested. The main purpose of the study is to find the maximum tolerated dose of everolimus when used together with standard chemotherapy. Everolimus has been found to be safe and effective in adults and children for treatment of T- and B-cell leukemias and lymphomas.

Conditions

• Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Everolimus	Given once daily orally via mouth or NG tube beginning at Dose Level (DL) 1 (4 mg/m2/day). Depending on safety and tolerability, dose levels will be escalated to DL2 (5 mg/m2/day). There is also a dose level de-escalation to DL0 (3 mg/m2/day) if toxicity is noted at DL1. Begins at Day 1 through 28.
DRUG	Nelarabine	650 mg/m2 IV daily x Day 1-5
DRUG	Cyclophosphamide	440 mg/m2 IV x Day 1-5
DRUG	Etoposide	100 mg/m2 IV x Day 1-5

Timeline

• Start date: 2018-07-24
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2017-11-01
• Last updated: 2023-07-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study