Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03740334
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Acute Lymphoblastic Leukemia ALL

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib, blocks a specific type of protein called a cyclin-dependent kinases (CDK)
  • Dexamethasone — DRUG
    Corticosteroids are commonly used to treat ALL.
  • Everolimus — DRUG
    Everolimus is an inhibitor of mTOR. mTOR inhibition blocks the translation of genes that regulate cancer cell proliferation

Study Details

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

Key Dates

Start date
Jan 30, 2019
Status verified
Nov 2025
Primary completion
Mar 4, 2023
Completion
Oct 1, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib (RIBO) + Dexamethasone (DEX)
    * Ribociclib administered daily for 21 consecutive days * Dexamethasone administered intravenously on days 1-5 and again on days 11-15
  • Experimental: RIBO + Everolimus (EVE) + DEX
    * Ribociclib administered daily for 21 consecutive days * Dexamethasone administered intravenously on days 1-5 and again on days 11-15 * Everolimus administered daily for 21 consecutive days
  • Experimental: RIBO + EVE+ DEX (dose expansion)
    * Ribociclib administered daily for 21 consecutive days. Dosing at RDE * Dexamethasone administered intravenously on days 1-5 and again on days 11-15 * Everolimus administered daily for 21 consecutive days. Dosing at RDE

Primary Outcome Measure

Pharmacokinetic analysis - AUC(0-24hr): [ Time Frame: 3 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
Nemours/Alfred I. duPont Hospital for ChildrenWilmingtonDelaware19803-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Boston Children's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10174-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, CONemours/Alfred I. duPont Hospital for Children· Wilmington, DEChildren's Healthcare of Atlanta· Atlanta, GABoston Children's Hospital· Boston, MADana Farber Cancer Institute· Boston, MADana-Farber Cancer Institute· Boston, MA

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