Ribociclib + Everolimus + Dexamethasone for Acute Lymphoblastic Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting the study drugs. Specifically, you must stop taking strong inducers or inhibitors of CYP3A4/5, medications with a narrow therapeutic window metabolized through CYP3A4/5, and certain herbal preparations at least 7 days before starting the study. Additionally, you must stop systemic corticosteroids 14 days before the study, but some uses like inhaled sprays are allowed.
What data supports the effectiveness of the drug combination Ribociclib, Everolimus, and Dexamethasone for treating Acute Lymphoblastic Leukemia?
Research shows that dexamethasone, a part of this drug combination, has been effective in treating acute lymphoblastic leukemia (ALL) when used with other drugs. Additionally, studies suggest that combining dexamethasone with other inhibitors can enhance its effectiveness in targeting leukemia cells.12345
What safety information is available for the combination of Ribociclib, Everolimus, and Dexamethasone in treating acute lymphoblastic leukemia?
Dexamethasone, used in treating acute lymphoblastic leukemia, can cause adverse reactions, especially in adolescents, and may lead to long-term issues like bone problems and heart issues. Everolimus has been tested with other drugs in children with relapsed leukemia, showing it can be combined safely, but specific safety data for the combination with Ribociclib is not detailed in the available research.46789
How is the drug combination of Ribociclib, Everolimus, and Dexamethasone unique for treating acute lymphoblastic leukemia?
This drug combination is unique because it combines Ribociclib, a CDK4/6 inhibitor, with Everolimus, an mTOR inhibitor, and Dexamethasone, a steroid, which may offer a novel approach by targeting different pathways in cancer cells compared to traditional chemotherapy regimens like hyper-CVAD.17101112
What is the purpose of this trial?
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
Research Team
Andrew Place, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for individuals aged between 1 and 30 years with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or CML in lymphoid blast crisis. They must have at least 1% lymphoblasts in their bone marrow, adequate organ function, no severe heart conditions, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with certain recent treatments, uncontrolled infections, HIV/Hepatitis A/B/C infection.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ribociclib, everolimus, and dexamethasone in combination. Ribociclib and everolimus are administered daily for 21 consecutive days, while dexamethasone is administered intravenously on days 1-5 and again on days 11-15.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pharmacokinetic analysis and toxicity assessments.
Treatment Details
Interventions
- Dexamethasone
- Everolimus
- Ribociclib
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania