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Corticosteroid

Ribociclib + Everolimus + Dexamethasone for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Led By Andrew E Place, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of graft-versus-host-disease (GVHD)
Primary refractory disease: Persistent disease after at least two induction attempts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is studying whether giving ribociclib and everolimus together with standard chemotherapy drugs may work better in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the effectiveness of ribociclib combined with everolimus and dexamethasone as a treatment for ALL that has returned after treatment or hasn't responded to previous therapies. It aims to see if this drug combination can help patients whose leukemia has been difficult to treat.See study design
What are the potential side effects?
Potential side effects include suppressed immune system leading to increased infection risk; mouth sores; diarrhea; fatigue; liver issues indicated by changes in blood tests; potential heart problems like abnormal heartbeat rhythm; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have symptoms of graft-versus-host disease.
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My condition did not improve after two initial treatments.
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I am on standard maintenance therapy excluding corticosteroids.
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My cancer has returned after treatment more than once or didn’t respond to the last treatment.
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My leukemia has returned or didn't respond to treatment, or my CML is in a severe phase and TKI treatments failed.
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I am receiving or have received spinal chemotherapy with specific drugs.
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My heart pumps well and I wasn't on heart medication during the test.
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I have waited long enough after my last monoclonal antibody treatment.
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I can do most activities by myself, regardless of my age.
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My body surface area is at least 0.4 square meters.
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My brain or spinal cord cancer is not in its most severe form.
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I am a woman who can have children and have a negative pregnancy test.
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I agree not to breastfeed while participating in this study.
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I am between 1 and 30 years old.
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My kidney function is normal or only slightly above normal.
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My bilirubin levels are within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Pharmacokinetic analysis - AUC(0-24hr)
Pharmacokinetic analysis - Cmax
+2 more
Secondary outcome measures
Overall Response Rate (ORR)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ribociclib (RIBO) + Dexamethasone (DEX)Experimental Treatment2 Interventions
Ribociclib administered daily for 21 consecutive days Dexamethasone administered intravenously on days 1-5 and again on days 11-15
Group II: RIBO + Everolimus (EVE) + DEXExperimental Treatment3 Interventions
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
Group III: RIBO + EVE+ DEX (dose expansion)Experimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Everolimus
2010
Completed Phase 4
~1510
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,613 Previous Clinical Trials
2,721,214 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,885 Total Patients Enrolled
Andrew E Place, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
92 Total Patients Enrolled
~7 spots leftby May 2025
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