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

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 24, 2018

Primary Completion Date

June 29, 2023

Study Completion Date

June 29, 2023

Conditions
Lymphoblastic LeukemiaLymphoblastic Lymphoma
Interventions
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

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

30322

Children's Healthcare of Atlanta, Atlanta

45229

Cincinnati Children's Hospital, Cincinnati

77030

Texas Children's Hospital, Houston

All Listed Sponsors
lead

Emory University

OTHER

NCT03328104 - Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma | Biotech Hunter | Biotech Hunter