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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

Must not have

Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges

Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any strong medication that affects liver enzymes, nor consuming specific citrus fruits.

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I am not planning to receive any non-study treatments like chemotherapy, radiation, or immunotherapy.

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I am not taking any herbal or dietary supplements.

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I have severe heart failure.

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I do not have Long QT syndrome or a family history of sudden death.

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I do not have serious heart conditions or irregular heart rhythms.

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I don't have low potassium or magnesium, heart failure, or slow heartbeat history.

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I do not have serious heart rhythm problems.

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I have been treated with a CDK4/6 inhibitor before.

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I do not have an active hepatitis A, B, or C infection.

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I do not have severe stomach or bowel problems that could affect medication absorption.

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I have an ongoing infection that hasn't improved with treatment.

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I have been diagnosed with cardiomyopathy.

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I am receiving treatment to help my body make more blood cells.

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I am currently on warfarin or similar blood thinners, but not heparin or LMWH.

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My condition does not improve with blood or platelet transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Pharmacokinetic analysis - AUC(0-24hr)

Pharmacokinetic analysis - Cmax

+2 more

Secondary study objectives

Overall Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Ribociclib

2018

Completed Phase 3

~2420

Dexamethasone

2007

Completed Phase 4

~2650