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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 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

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

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,935 Total Patients Enrolled

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,720,990 Total Patients Enrolled

Andrew E Place, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

92 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to take part in this clinical experiment?

"To qualify for this medical experiment, participants must have a diagnosis of leukemia and be between 1 year old to 30. 45 people are needed in total."

Answered by AI

Is this research study currently enlisting participants?

"This clinical trial is not currently seeking new patient enrolment. Initially posted on January 30th 2019 and last modified on May 16th 2022, it does not presently have any open recruitment. For those looking for similar studies, 1498 trials recruiting patients with leukemia are available as well as 688 actively admitting individuals to investigate Ribociclib's efficacy."

Answered by AI

Has Ribociclib been tested in any additional scientific experiments?

"Currently, there are 688 trials actively researching Ribociclib with 167 of those in Phase 3. In Mishawaka, Indiana alone multiple studies for this drug are running concurrently; across the globe 24026 locations are hosting clinical trials regarding Ribociclib."

Answered by AI

Are there age requirements for the participants of this trial?

"The requirements for inclusion in this clinical trial dictate that participants must fall between 1 year and 30 years of age. There are 559 trials available to minors, while the elderly have access to 1796 separate studies."

Answered by AI

How many participants are participating in this medical study?

"This trial is no longer recruiting new participants, having been initially posted on January 30th 2019 and last edited on May 16th 2022. If you are seeking other medical studies there are presently 1498 trials for leukemia patients actively searching for volunteers and 688 research projects associated with Ribociclib looking to enrol people."

Answered by AI

What is the risk profile of Ribociclib usage?

"Due to the preliminary nature of this research, Ribociclib was given a score of 1 for safety as there is limited clinical evidence supporting its efficacy and security."

Answered by AI

What diseases or conditions is Ribociclib typically prescribed for?

"Ribociclib is often prescribed to treat advanced renal cell carcinoma that has become unresponsive to other treatments. It may also be effective in managing ophthalmia, sympathetic conditions, branch retinal vein occlusion and macular edema."

Answered by AI

How many medical centers are actively conducting this experiment?

"This trial is taking place at a number of sites, such as Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delaware, Children's Hospital of Wisconsin in Milwaukee, Wisconsin and Dana-Farber Cancer Institute in Boston Massachusetts; with 10 other medical centres also included."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL

Andrew E. Place, MD 2019. "Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03740334.

All > Paid Studies Delaware