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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 belowSelect...
I was diagnosed before turning 1 year old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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)
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 moreAwards & 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
Pegaspargase
2005
Completed Phase 3
~9260
Bortezomib
2005
Completed Phase 3
~1410
Cyclophosphamide
2010
Completed Phase 4
~2310
Leucovorin Calcium
2011
Completed Phase 3
~12500
Vorinostat
2014
Completed Phase 3
~1600
Etoposide
2010
Completed Phase 3
~2960
Cytarabine
2016
Completed Phase 3
~3330
Mercaptopurine
2012
Completed Phase 4
~12550
Methotrexate
2019
Completed Phase 4
~4400
Vincristine
2003
Completed Phase 4
~2970
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,431 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,437 Total Patients Enrolled
Baylor College of MedicineOTHER
1,025 Previous Clinical Trials
6,029,732 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed before turning 1 year old.I have been diagnosed with mature B-cell ALL or AML.I have been newly diagnosed with a specific type of leukemia with a high number of cancer cells in my bone marrow.I've had minimal prior cancer treatment, including short-term use of specific medications.I have received treatments not listed in the trial's accepted therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.