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Protein-Drug Conjugate

Tagraxofusp for Blood Cancers

Phase 1
Recruiting
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
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 at the end of cycle 1 (21 days for part 1, and 28 days for part 2)
Awards & highlights

Study Summary

This trial is examining the safety of tagraxofusp, a novel agent that targets CD123, in pediatric patients with relapsed/refractory hematologic malignancies. The trial includes two parts: a monotherapy phase and a combination chemotherapy phase. The goal is to determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients.

Who is the study for?
This trial is for children and young adults aged 1 to 21 with relapsed or refractory hematologic malignancies expressing CD123. Eligible participants include those with various types of leukemia, lymphoma, and myelodysplastic syndrome who have experienced multiple relapses or did not respond to at least two chemotherapy cycles. Patients must have adequate organ function and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests Tagraxofusp alone and in combination with other chemotherapies (like Hydrocortisone, Dexamethasone) in pediatric patients. It aims to determine the safe dosage levels, describe side effects, understand how the drug works in the body, and improve survival rates for these cancers.See study design
What are the potential side effects?
Possible side effects may include reactions related to diphtheria toxin such as fever or nausea; however specific side effects are being studied as part of this trial's purpose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of cycle 1 (21 days for part 1, and 28 days for part 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 1 (21 days for part 1, and 28 days for part 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of dose limiting toxicity (DLT) during cycle 1 of therapy

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2 - Cohort CExperimental Treatment5 Interventions
Tagraxofsup -Days 1-5 Azacitidine -Days 1-5 IT Therapy (may include methotrexate, cytarabine, or triple IT) CNS1 IT Therapy Day 1 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator CNS2/3 IT Therapy Days 1, 8, 15, and 22 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator
Group II: Part 2 - Cohort BExperimental Treatment6 Interventions
Tagraxofsup -Days 8-12 Dexamethasone -Days 1-5 Vincristine -Days 1, 8, 15, and 22 IT Therapy (may include methotrexate, cytarabine, or triple IT) CNS1 IT Therapy Day 1 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator CNS2/3 IT Therapy Days 1, 8, 15, and 22 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator
Group III: Part 2 - Cohort AExperimental Treatment6 Interventions
Tagraxofsup -Days 4-8 Fludarabine -Days 1-5 Cytarabine -Days 1-5 IT Therapy (may include methotrexate, cytarabine, or triple IT) CNS1 IT Therapy Day 1 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator CNS2/3 IT Therapy Days 1, 8, 15, and 22 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator
Group IV: Part 1Experimental Treatment4 Interventions
Tagraxofusp -Days 1-5 IT Therapy (may include methotrexate, cytarabine, or triple IT) Day 1 Patients may receive additional IT therapy with their end-of-cycle disease re-evaluation at the discretion of the treating investigator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Methotrexate
2013
Completed Phase 4
~3800
Azacitidine
2012
Completed Phase 3
~1410
Hydrocortisone
2005
Completed Phase 4
~1280
Vincristine
2003
Completed Phase 4
~2910
Fludarabine
2012
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
623 Total Patients Enrolled
Adam Lamble, MDStudy ChairSeattle Children's

Media Library

Tagraxofusp (Protein-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05476770 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Part 1, Part 2 - Cohort C, Part 2 - Cohort A, Part 2 - Cohort B
Acute Lymphoblastic Leukemia Clinical Trial 2023: Tagraxofusp Highlights & Side Effects. Trial Name: NCT05476770 — Phase 1
Tagraxofusp (Protein-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05476770 — Phase 1
~25 spots leftby Nov 2025
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