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Alkylating agents

Everolimus for Lymphoblastic Leukemia (ENCERT Trial)

Phase 1
Waitlist Available
Led By Himalee Sabnis, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 8 and 15 and day 29/ at count recovery at the end of course 1 (whichever is earlier)
Awards & highlights

ENCERT Trial Summary

This trial is testing a new cancer drug, everolimus, to see what the maximum tolerated dose is when used with standard chemotherapy for T-cell leukemia/lymphoma.

Eligible Conditions
  • Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma

ENCERT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 8 and 15 and day 29/ at count recovery at the end of course 1 (whichever is earlier)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 8 and 15 and day 29/ at count recovery at the end of course 1 (whichever is earlier) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the maximum tolerated dose (MTD).
Secondary outcome measures
Changes in Mer expression at time points pre- and post everolimus therapy in peripheral blood mono-nuclear cells (PBMCs) and bone marrow.
Changes in phosphoprotein (pAkt and p4EBP1) expression at time points pre- and post everolimus therapy in peripheral blood mono-nuclear cells (PBMCs) and bone marrow.
Determine area under the concentration versus time curve (AUC)
+4 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107
20%
Hospitalization
20%
Immunosuppression held or modified
10%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Low Intensity Tacrolimus

ENCERT Trial Design

1Treatment groups
Experimental Treatment
Group I: Everolimus in combination with standard chemotherapyExperimental Treatment4 Interventions
A treatment course lasts 28 days, during which participants take everolimus by mouth every day and also get standard chemotherapy via IV on certain days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelarabine
FDA approved
Everolimus
FDA approved
Etoposide
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,646 Previous Clinical Trials
2,564,592 Total Patients Enrolled
Himalee Sabnis, MD5.01 ReviewsPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
8 Total Patients Enrolled
~1 spots leftby Jun 2025
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