Ribociclib + Everolimus + Dexamethasone for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+11 other locations

Andrew E. Place, MD, PhD - Dana-Farber ...

Overseen byAndrew Place, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

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

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

I haven't taken systemic corticosteroids in the last 14 days, but I may have used them topically, inhaled, as eye drops, or locally.

I received radiation for chloroma without needing a waiting period.

I do not have symptoms of graft-versus-host disease.

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Exclusion Criteria

I have not taken long-acting medications like Neulasta in the last 14 days.

Inability to determine the QTcF interval on screening EKG (using Fridericia's correction)

I have had cancer before, but it wasn't acute lymphoblastic leukemia (ALL).

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Everolimus (mTOR Inhibitor)
Ribociclib (CDK4/6 Inhibitor)

Trial OverviewThe 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.

Participant Groups

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

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for: