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Tagraxofusp for Leukemia Maintenance Post-Transplant

Phase 1

Recruiting

Led By Karen Ballen

Research Sponsored by Karen Ballen, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has adequate baseline organ function including cardiac, renal, and hepatic function within 28 days of start of therapy: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG), Serum Creatinine ≤ 1.5 mg/dL, Bilirubin ≤1.5 mg/dL, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN), Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, Platelets ≥ 80,000/mm^3, Serum albumin ≥3.2 (note that albumin infusions are not permitted in order to enable eligibility)

Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed through 2 years after date of hct

Awards & highlights

Study Summary

This trial is testing the use of tagraxofusp to prevent relapse in patients with leukemia who have undergone allogeneic stem cell transplant.

Who is the study for?

Adults aged 18-75 with CD123+ myelofibrosis, chronic myelomonocytic leukemia, or acute myeloid leukemia who've had a stem cell transplant within the last 60-120 days. They should be in remission post-transplant and have good organ function. Participants must agree to use contraception and adhere to lifestyle guidelines.Check my eligibility

What is being tested?

The trial is testing Tagraxofusp as a maintenance therapy after allogeneic stem cell transplant for patients with certain blood cancers. It aims to prevent cancer relapse over up to nine treatment cycles, including bone marrow biopsies after cycle four and around one year post-transplant.See study design

What are the potential side effects?

Specific side effects of Tagraxofusp are not listed but may include reactions at the infusion site, potential liver issues (as indicated by eligibility criteria on bilirubin levels), fatigue, immune system impacts (based on neutrophil count requirements), and other common drug-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed through 2 years after date of hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed through 2 years after date of hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed through 2 years after date of hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities

Incidence and severity of grade ≥ 3 adverse events

Percent of planned tagraxofusp dose received

Secondary outcome measures

Frequency and severity of acute GVHD grades II-IV and chronic GVHD

Time from HCT to relapse and death or last contact.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tagraxofusp (escalating doses)Experimental Treatment1 Intervention

IV tagraxofusp on days 1-3 of cycles 1-4 and days 1-2 of additional cycles for up to 9 cycles (some participants could receive more if considered in their best interest)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karen Ballen, MDLead Sponsor

Karen BallenPrincipal InvestigatorUVA

Media Library

Tagraxofusp Clinical Trial Eligibility Overview. Trial Name: NCT05233618 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Tagraxofusp (escalating doses)

Acute Myeloid Leukemia Clinical Trial 2023: Tagraxofusp Highlights & Side Effects. Trial Name: NCT05233618 — Phase 1

Tagraxofusp 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233618 — Phase 1

Frequently Asked Questions

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

Is this experiment still enrolling participants?

"Affirmative. As per clinicaltrials.gov, this inquiry has been recruiting since July 13th 2022 and is still open for applications with the most recent update occurring on July 17th 2022. 44 individuals will be recruited from a single site to partake in these proceedings."

Answered by AI

What is the magnitude of participants that have enrolled in this research project?

"That is correct. Clinicaltrials.gov's records state that, as of July 17th 2022, this clinical trial has begun recruiting participants. 44 individuals are being invited to join the study at a single site and applications were first opened on July 13th 20202."

Answered by AI

Has Tagraxofusp been officially sanctioned by the FDA?

"Tagraxofusp has been assessed to be a level 1 on the safety scale due its limited available data suggesting efficacy and security."

Answered by AI

Am I eligible to participate in this experiment?

"This clinical trial is searching for 44 people between the ages of 18 and 75 suffering from primary myelofibrosis. Additionally, participants must have an expected life span longer than 6 months, possess a ECOG performance status ranging between 0-2, maintain at least 50% ejection fraction in their left ventricle as measured by MUGA or 2D ECHO scans with no medically concerning findings on their 12 lead ECG, demonstrate creatinine clearance levels above 60 ml/min according to Cockcroft's Gault equation, not exceed 1.5 mg/dL bilirubin concentration in serum samples, keep AST and"

Answered by AI

Are those aged 50+ eligible to participate in the investigation?

"This trial requires participants to have a minimum age of 18 and a maximum age of 75. For those below 18 or above 65, there are 450 trials for the former and 1321 for the latter."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MF and CMML (HSCT 002)

Karen Ballen, MD 2022. "Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MF and CMML (HSCT 002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233618.

All > Myelofibrosis