Bcl-2 Inhibitor

Block 2 for Acute Lymphoblastic Leukemia

Q: For what kind of ailments is Block 1 typically administered?

<p>Block 1 has demonstrated efficacy in the management of <a href="https://www.withpower.com/clinical-trials/mac">mac</a>ular edema, pheochromocytomas, and ocular maladies.</p>

St. Jude Children's Research Hospital, Memphis, TN

Targeting 2 different conditionsEtoposide +16 morePhase 1 & 2RecruitingLed by Seth E. Karol, MDResearch 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

- Patients with a history of reduced LVEF which subsequently improved with medical management are eligible if they meet the criteria above.

-- Patient has not had prior exposure to navitoclax

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow ups1, 3, and 5 years from study entry

Awards & highlights

Approved for 60 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

Relapsed Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

If you had a previous problem with your heart's pumping ability (LVEF), but it got better with medicine, you can still participate if you meet the other requirements.

Select...

You have not taken navitoclax before.

Select...

Extra requirements for special groups participating in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

Follow ups ~ 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

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

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

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

Etoposide

FDA approved

Navitoclax

Not yet FDA approved

Cytarabine

FDA approved

Cyclophosphamide

FDA approved

Blinatumomab

FDA approved

Dasatinib

FDA approved

Methotrexate

FDA approved

Mercaptopurine

FDA approved

Leucovorin

FDA approved

Venetoclax

FDA approved

Dexamethasone

FDA approved

Asparaginase Escherichia coli

FDA approved

Asparaginase Erwinia chrysanthemi

FDA approved

Radiation

2005

Completed Phase 3

~990

Vincristine

FDA approved

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

AbbVieIndustry Sponsor

893 Previous Clinical Trials

483,461 Total Patients Enrolled

St. Jude Children's Research HospitalLead Sponsor

417 Previous Clinical Trials

5,304,134 Total Patients Enrolled

Seth E. Karol, MDPrincipal Investigator

St. Jude Children's Research Hospital

2 Previous Clinical Trials

93 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.