Tagraxofusp for Leukemia, Myelocytic, Acute

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, Myelocytic, Acute+15 More
Tagraxofusp - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • 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

1 of 3

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)

Day 28
Occurrence of dose limiting toxicity (DLT) during cycle 1 of therapy

Trial Safety

Safety Progress

1 of 3

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

Part 1Experimental Group · 4 Interventions: Hydrocortisone, Methotrexate, Cytarabine IT, Tagraxofusp · Intervention Types: Drug, Drug, Drug, Drug
Part 2 - Cohort AExperimental Group · 6 Interventions: Hydrocortisone, Methotrexate, Cytarabine, Cytarabine IT, Tagraxofusp, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Part 2 - Cohort BExperimental Group · 6 Interventions: Hydrocortisone, Methotrexate, Vincristine, Cytarabine IT, Dexamethasone, Tagraxofusp · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Part 2 - Cohort CExperimental Group · 5 Interventions: Azacitidine, Hydrocortisone, Methotrexate, Cytarabine IT, Tagraxofusp · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1660
Hydrocortisone
2005
Completed Phase 4
~4900
Methotrexate
2013
Completed Phase 4
~3710
Cytarabine
2016
Completed Phase 3
~3090
Vincristine
2003
Completed Phase 4
~2920
Dexamethasone
2007
Completed Phase 4
~2420
Fludarabine
2012
Completed Phase 3
~1170

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of cycle 1 (21 days for part 1, and 28 days for part 2)

Who is running the clinical trial?

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

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of the disease.\n
The percentage of blasts in the bone marrow aspirate by morphology or flow cytometry is greater than 5%.
You have B-cell precursor lymphoma (B-CLL) or B-cell lymphoma, not otherwise specified (B-NOS) in the first or second relapse after 1 or more chemotherapy cycles.

About The Reviewer

Michael Gill preview

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.