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Immunotherapy for Infant Leukemia

Phase 1 & 2
Recruiting
Led By Tanja A Gruber, MD, PhD
Research Sponsored by Tanja Andrea Gruber
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve treatment for persistent leukemia with a type of immunotherapy that targets the leukemia cells' outer membrane. #leukemia #immunotherapy #CD19

Who is the study for?
This trial is for infants up to 1 year old with a new diagnosis of CD19 positive acute lymphoblastic leukemia or related conditions, with limited prior treatment. They must have more than 25% leukemia cells in their bone marrow and can have some previous short-term treatments like hydroxyurea or glucocorticoids.
What is being tested?
The TINI 2 study aims to improve the initial TINI study by testing blinatumomab's effectiveness in clearing persistent leukemia. Blinatumomab is an immunotherapy that targets CD19 on the surface of leukemia cells, along with other drugs like Mercaptopurine and Methotrexate.
What are the potential side effects?
Possible side effects include reactions at the infusion site, immune system complications, fatigue, nausea, liver issues from Mercaptopurine, nerve damage from Vincristine, and blood disorders due to chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Minimal Residual Disease
Secondary study objectives
Event Free Survival
Overall Survival
Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy

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 Treatment9 Interventions
Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 3
~1410
Vorinostat
2014
Completed Phase 3
~1600
Mercaptopurine
2012
Completed Phase 4
~12550
Methotrexate
2019
Completed Phase 4
~4400
Blinatumomab
2014
Completed Phase 3
~1230
Dexamethasone
2007
Completed Phase 4
~2650
Mitoxantrone
2008
Completed Phase 3
~1550

Find a Location

Who is running the clinical trial?

Lucile Packard Children's Hospital FoundationUNKNOWN
Kura OncologyUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Kura Oncology, Inc.Industry Sponsor
17 Previous Clinical Trials
1,487 Total Patients Enrolled

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05848687 — Phase 1 & 2
Lymphoblastic Leukemia Research Study Groups: Treatment
Lymphoblastic Leukemia Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT05848687 — Phase 1 & 2
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848687 — Phase 1 & 2
~60 spots leftby Dec 2028
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