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.
- Lymphoma, Hodgkins
- ALL
- Leukemia, Myelocytic, Acute
- Mixed Phenotype Acute Leukemia (MPAL)
- BPDCN
- Acute Undifferentiated Leukemia (AUL)
- Lymphoma, B-Cell
- Malignancies, Hematologic
- MDS
- Lymphoma
- Lymphoma, T-Cell
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: At the end of Cycle 1 (21 days for Part 1, and 28 days for Part 2)
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Part 1
1 of 4
Part 2 - Cohort A
1 of 4
Part 2 - Cohort B
1 of 4
Part 2 - Cohort C
1 of 4
Experimental Treatment
54 Total Participants · 4 Treatment Groups
Primary Treatment: Tagraxofusp · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 31st, 2021
Last Reviewed: November 4th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.