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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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I was diagnosed before turning 1 year old.

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

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

Primary outcome measures

Percentage of Treatment-related Mortality (TRM)

Secondary outcome measures

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

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

~2590

Mitoxantrone

2008

Completed Phase 3

~1510

Pegaspargase

2005

Completed Phase 3

~9010

Bortezomib

2005

Completed Phase 2

~1140

Cyclophosphamide

1995

Completed Phase 3

~3770

Leucovorin Calcium

2011

Completed Phase 3

~12310

Vorinostat

2014

Completed Phase 3

~1600

Etoposide

2010

Completed Phase 3

~2440

Cytarabine

2016

Completed Phase 3

~3310

Mercaptopurine

2012

Completed Phase 4

~12330

Methotrexate

2013

Completed Phase 4

~3800

Vincristine

2003

Completed Phase 4

~2910

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,563 Total Patients Enrolled

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,520 Total Patients Enrolled

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,002,202 Total Patients Enrolled

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02553460 — Phase 1 & 2

Acute Lymphoblastic Leukemia Research Study Groups: Treatment

Acute Lymphoblastic Leukemia Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT02553460 — Phase 1 & 2

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02553460 — Phase 1 & 2

Frequently Asked Questions

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

Are there any other investigations surrounding the use of ITMHA?

"Presently, 2027 clinical trials testing ITMHA are in progress with 463 of these being conducted at the Phase 3 level. The majority of experiments for this medication occur near Houston, Texas yet 69963 sites offer opportunities to join a trial."

Answered by AI

What is the total number of healthcare facilities conducting this experiment?

"This experiment is currently enrolling participants at 18 different treatment centres, including CHKD in Norfolk, Children's & Women's Health Centre of British Columbia and McMaster Children's Hospital in Hamilton."

Answered by AI

Is this experiment open for enrollment at present?

"Unfortunately, patients should not expect to be recruited for this medical trial as it is no longer actively seeking participants. The original listing date was January 29th 2016 and the most recent update occured on June 6th 2022. However, there are 3,522 other clinical trials currently searching for volunteers in lieu of this one."

Answered by AI

What conditions are typically treated with ITMHA?

"ITMHA is primarily used for macular edema, but it also has applications in the treatment of pheochromocytomas, eye issues and ulcerative colitis."

Answered by AI

How many volunteers have been enlisted for this trial?

"Unfortunately, this trial has stopped recruiting for the time being. It was initially posted on January 29th 2016 and had its last update on June 6th 2022. However, there are other studies related to leukemia, lymphocytic acute L1 and ITMHA where 1495 trials and 2027 trials respectively are actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

2016. "Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02553460.

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