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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 1 (21 days for part 1, and 28 days for part 2)

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

~1440

Hydrocortisone

2005

Completed Phase 4

~1260

Vincristine

2003

Completed Phase 4

~2910

Fludarabine

2012

Completed Phase 3

~1100

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous facilities in Canada that are currently conducting this trial?

"At present, this medical study is recruiting participants from 27 different healthcare facilities. These include the Children's Hospital of Philadelphia in Philadelphia, Cook Children's Hospital in Fort Worth, and Primary Children's Hospital in Salt Lake City as well as other sites."

Answered by AI

Am I eligible to be a participant in this research study?

"This trial seeks 54 juveniles between the ages of one and 21 with relapsed or refractory hematologic malignancies, including acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, , Hodgkin lymphoma, non-Hodgkin lymphoma and blastic plasmacytoid dendritic cell neoplasms. Participants must demonstrate surface expression of CD123 in their tumour cells by flow cytometry or immunohistochemistry at enrolment. To qualify for Monotherapy Part 1 they must have had a second relapse or be refractory after"

Answered by AI

Can any new participants join the research experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was posted on November 11th 2022, is currently searching for test subjects. 54 participants need to be recruited from a total of 27 sites."

Answered by AI

Are individuals above an octogenarian age ineligible for this investigation?

"This trial is available for participants between 1 Year and 21 years old. In comparison, there are 918 clinical trials focused on minors, while 4703 experiments focus on geriatric populations."

Answered by AI

How many individuals have registered to partake in this research?

"Affirmative. Clinicaltrials.gov data proves that this clinical trial, originally posted on November 11th 2022 is actively recruiting patients. 54 participants need to be recruited from 27 different medical sites around the country."

Answered by AI

What is the FDA's current stance on Tagraxofusp?

"The safety rating for Tagraxofusp was established as 1, since this phase one trial has limited evidence in its favor concerning efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

2022. "Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05476770.

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