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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
1,638 Previous Clinical Trials
2,560,524 Total Patients Enrolled
Himalee Sabnis, MD5.01 ReviewsPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous locations administering this trial within the state?

"Currently, the trial is accepting patients at four locations: New york, Cincinnati and Atlanta among others. To reduce travel demands associated with participation in this study, it's important to register at a medical center close to you."

Answered by AI

What medical conditions commonly prompt a prescription for Everolimus?

"Everolimus is a commonly prescribed treatment for leukemia and has shown to be successful in mitigating refractory advanced renal cell carcinoma, prostate cancer, and lung cancers."

Answered by AI

How many participants are being welcomed into this medical study?

"Affirmative. The information posted on clinicaltrials.gov reveals that this research endeavour, which was first introduced on July 24th 2018 is currently searching for participants. A total of 15 individuals are expected to enrol from across 4 distinct centres."

Answered by AI

Are there any recorded attempts to use Everolimus for medical purposes in the past?

"Everolimus was first studied in 1997 at the City of Hope Comprehensive Cancer Center. To date, 1758 trials have been completed and 1082 are actively recruiting new participants. Of these active studies, many are based in New york City."

Answered by AI

Is the age cap for this research project 45 years and above?

"This medical trial is limited to those between the ages of 2 and 29. There are 982 studies for minors, while elder patients have access to 3312 clinical trials."

Answered by AI

To what extent is Everolimus a secure treatment option for patients?

"The safety of Everolimus is rated a 1 because it has yet to go through the necessary trials for full efficacy and safety testing."

Answered by AI

Is this experimental research still open for participants?

"As indicated on clinicaltrials.gov, this medical experiment has been actively seeking participants since its initial posting date of July 24th 2018 and was last modified on August 18th 2022."

Answered by AI

Who may partake in the experiment, taking into consideration all eligibility requirements?

"Recruitment for this trial is actively seeking 15 individuals suffering from leukemia ranging in age between 2 and 29. Eligibility requirements are outlined as follows: CNS status may be accepted if other sites of malignancy exist, performance score must meet either Karnofsky or Lansky standards (depending on subject's age), patients rendered immobile due to paralysis will still qualify as ambulatory, histology confirming diagnosis at the onset or relapse, 1 year old minimum with 30 years being the upper limit. Lymphoma sufferers also eligible."

Answered by AI
~1 spots leftby Apr 2025