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Bcl-2 Inhibitor

Venetoclax + Navitoclax for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Led By Seth E. Karol, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, and 5 years from study entry

Awards & highlights

Study Summary

This trial is studying a combination of drugs, venetoclax and navitoclax, to see how well they work in treating children with relapsed or refractory acute lymphoblastic leukemia or lymphoma.

Who is the study for?

This trial is for children and young adults aged 4 to under 30 with relapsed or refractory acute lymphoblastic leukemia/lymphoma. They must have certain levels of disease in the bone marrow or blood, be able to swallow pills, have no severe heart issues, and not have had certain recent treatments. Those with Down Syndrome are eligible only for specific parts of the study.Check my eligibility

What is being tested?

The trial tests a combination chemotherapy using venetoclax and navitoclax on patients with relapsed leukemia/lymphoma. It aims to find the best dose when combined with either blinatumomab (for CD19-positive patients) or high-dose cytarabine (for CD19-negative patients), comparing results against past data.See study design

What are the potential side effects?

Possible side effects include digestive problems, liver issues reflected by increased enzymes, fatigue, potential impact on heart function, lowered resistance to infections due to weakened immune system response from chemotherapy drugs involved.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, and 5 years from study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, and 5 years from study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, and 5 years from study entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minimal Residual Disease (MRD)-negative response

Recommended Phase 2 dose of venetoclax in combination with a) high-dose cytarabine and navitoclax or b) blinatumomab

Secondary outcome measures

Event Free Survival (EFS)

Grade 3 or higher CTCAE events in block 2a

Grade 3 or higher CTCAE events in block 2b

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Block 2Experimental Treatment17 Interventions

Block 2a Therapy: Patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Cytarabine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, IT MHA, Radiation Block 2b Therapy: Patients receive intervention according to the Detailed Description section with the following: Venetoclax, Blinatumomab, Dexamethasone, Dasatinib, IT MHA Following Block 2 of therapy, late (≥36 months from diagnosis) first relapse B-ALL who are MRD negative after Block 1 will continue chemotherapy using adapted R3 intensification, interim, and continuation therapies. Patients receive intervention according to the Detailed Description section with the following: Methotrexate, Mercaptopurine, IT MHA, Leucovorin, Dexamethasone, Vincristine, Cyclophosphamide, Etoposide, Cytarabine, Dasatinib, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Radiation

Group II: Block 1Experimental Treatment10 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

2005

Completed Phase 4

~5730

Navitoclax

2012

Completed Phase 2

~90

Blinatumomab

2014

Completed Phase 3

~1210

Methotrexate

2013

Completed Phase 4

~3800

Cyclophosphamide

1995

Completed Phase 3

~3770

Etoposide

2010

Completed Phase 3

~2440

Cytarabine

2016

Completed Phase 3

~3310

Dasatinib

2012

Completed Phase 3

~2320

Mercaptopurine

2012

Completed Phase 4

~12330

Venetoclax

2019

Completed Phase 3

~1990

Dexamethasone

2007

Completed Phase 4

~2590

Pegaspargase

2005

Completed Phase 3

~9010

Erwinia asparaginase

2012

Completed Phase 2

~30

Radiation

2003

Completed Phase 3

~1010

Vincristine

2003

Completed Phase 4

~2910

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

964 Previous Clinical Trials

503,227 Total Patients Enrolled

St. Jude Children's Research HospitalLead Sponsor

429 Previous Clinical Trials

5,306,660 Total Patients Enrolled

Seth E. Karol, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

943 Total Patients Enrolled

Media Library

Venetoclax and Navitoclax (Bcl-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05192889 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Block 2, Block 1

Acute Lymphoblastic Leukemia Clinical Trial 2023: Venetoclax and Navitoclax Highlights & Side Effects. Trial Name: NCT05192889 — Phase 1 & 2

Venetoclax and Navitoclax (Bcl-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05192889 — Phase 1 & 2

Frequently Asked Questions

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

Does the eligibility of this trial extend to adults above 30 years old?

"This trial is seeking out participants who are aged between 4 and 30 years."

Answered by AI

What is the purpose of this research endeavor?

"This clinical trial plans to assess the Recommended Phase 2 dose of venetoclax over a 4 week period. The main objective will encompass either high-dose cytarabine and navitoclax or blinatumomab therapies, while secondary objectives include Grade 3 CTCAE events in block 2b, Event Free Survival (EFS) estimates using Kaplan-Meier method as well as Overall Survival (OS) utilizing similar techniques."

Answered by AI

For what kind of ailments is Block 1 typically administered?

"Block 1 has demonstrated efficacy in the management of macular edema, pheochromocytomas, and ocular maladies."

Answered by AI

Are researchers currently accepting participants for this trial?

"Affirmative. According to the clinicaltrials.gov database, this medical trial has been launched since August 25th 2022 and continues to actively enroll participants. The endeavour is looking for 90 individuals from a single site."

Answered by AI

Has Block 1 been previously subjected to any other clinical examinations?

"Currently, there are 2,218 clinical trials exploring Block 1; 489 of these studies have entered Phase 3. Changsha in Hunan holds the most live investigations for this medication, with 79,288 different sites contributing to its research."

Answered by AI

How many participants are currently being accepted into this research endeavor?

"Affirmative. According to the clinicaltrials.gov portal, this investigation is still enrolling participants; it was originally uploaded on August 25th 2022 and updated recently on September 1st 2022. The trial requires 90 test subjects from a single centre."

Answered by AI

Am I eligible to enroll in this medical trial?

"Eligibility criteria for this medical experiment includes a diagnosis of leukemia and being aged between 4 and 30. A total of 90 participants are needed to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

2022. "Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05192889.

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