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Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL

NCT03740334 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-21

No results posted yet for this study

Summary

This research study is evaluating a drug called ribociclib (LEE011) given in combination with everolimus and other standard of care chemotherapy drugs as a possible treatment for relapsed or refractory ALL.

The names of the drugs involved in this study are:

* ribociclib
* everolimus
* dexamethasone

Conditions

  • Acute Lymphoblastic Leukemia ALL

Interventions

DRUG

Everolimus

Everolimus is an inhibitor of mTOR. mTOR inhibition blocks the translation of genes that regulate cancer cell proliferation

DRUG

Ribociclib

Ribociclib, blocks a specific type of protein called a cyclin-dependent kinases (CDK)

DRUG

Dexamethasone

Corticosteroids are commonly used to treat ALL.

Sponsors & Collaborators

Principal Investigators

  • Andrew E Place, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2023-03-04
Completion
2026-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740334 on ClinicalTrials.gov