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

First listed
Nov 14, 2018
Start date
Jan 30, 2019
Status verified
Aug 2026
Primary completion
Mar 4, 2023
Completion
Apr 30, 2027

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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