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Bcl-2 Inhibitor

Venetoclax + Navitoclax for Acute Lymphoblastic Leukemia

Phase 1 & 2

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

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 study objectives

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

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

Navitoclax

2015

Completed Phase 2

~150

Cytarabine

2016

Completed Phase 3

~4020