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Proteasome Inhibitor

Chemotherapy with Bortezomib + Vorinostat for Acute Lymphoblastic Leukemia

Phase 1 & 2

Waitlist Available

Led By Sima Jeha, 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

Patient is ≤ 365 days of age at the time of diagnosis

Be younger than 18 years old

Must not have

Patients with mature B-cell ALL or acute myelogenous (AML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), end of reinduction (approximately 19 weeks), end of reintensification (approximately 23 weeks), and end of maintenance therapy (approximately 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the effects of adding the drugs bortezomib and vorinostat to chemotherapy for treating infants with acute lymphoblastic leukemia. The drugs may help to decrease the number of leukemia cells, but could also cause additional side effects.

Who is the study for?

This trial is for infants under the age of 1 with newly diagnosed acute lymphoblastic leukemia (ALL) or similar conditions, with a significant number of leukemia cells in their bone marrow. Infants who have received very limited prior treatment and do not have mature B-cell ALL, AML, or Down syndrome can participate.

What is being tested?

The study tests bortezomib and vorinostat combined with standard chemotherapy to treat infant ALL. These drugs are FDA-approved for adult cancers but not yet for children's leukemia. The goal is to see if they're tolerable and effective at reducing leukemia cells without causing too many side effects.

What are the potential side effects?

Potential side effects include reactions specific to bortezomib and vorinostat which may involve nerve damage, digestive issues, blood count changes, fatigue, and increased risk of infection. Side effects from the standard chemotherapy could also occur.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed before turning 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with mature B-cell ALL or AML.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), end of reinduction (approximately 19 weeks), end of reintensification (approximately 23 weeks), and end of maintenance therapy (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), end of reinduction (approximately 19 weeks), end of reintensification (approximately 23 weeks), and end of maintenance therapy (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of induction (approximately 6 weeks), end of consolidation (approximately 14 weeks), end of reinduction (approximately 19 weeks), end of reintensification (approximately 23 weeks), and end of maintenance therapy (approximately 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Treatment-related Mortality (TRM)

Secondary study objectives

3-year Event Free Survival (EFS)

5-year Overall Survival (OS)

Minimal Residual Disease (MRD) Positivity Using Flow Cytometry at Day 22, End of Induction, End of Consolidation, and End of Maintenance.

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment14 Interventions

Participants who meet eligibility requirements will receive remission induction, consolidation treatment, reinduction, reintensification and maintenance therapy. Interventions: ITMHA, dexamethasone, mitoxantrone, pegaspargase or asparaginase Erwinia chrysanthemi, bortezomib, vorinostat, cyclophosphamide, mercaptopurine, methotrexate, leucovorin calcium, cytarabine, etoposide, and vincristine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Mitoxantrone

2008

Completed Phase 3

~1550