TerminatedPhase 2

Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant

Stopped: The protocol was terminated early due to slow participant accrual and the sponsor not willing to provide the study drug.

United States3 participantsStarted 2020-03-27

Plain-language summary

This phase II trial studies the side effects of tagraxofusp in treating patients with blastic plasmacytoid dendritic cell neoplasm after stem cell transplant. Tagraxofusp is a type of immunotoxin that is made by linking a protein called IL-3 to a toxic substance. Tagraxofusp may help find cancer cells that express IL-3 and kill them without harming normal cells.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eligible patients will be aged \>= 18 years. Pediatric patients age 2 years and older will be considered on a case by case basis. * Diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) according to World Health Organization (WHO) classification or confirmed by hematopathology * The patients must be in partial response or better * \> 30 days post-transplant without active or chronic infections * Karnofsky performance status \>= 60%; Lansky \>= 60 * Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal by multigated acquisition (MUGA) scan or echocardiogram within 30 days of first protocol treatment * Diffusion capacity of the lung for carbon monoxide (DLCO) \> 40% of predicted value (corrected for hemoglobin) within 3 months of registration * Forced expiratory volume in 1 second (FEV1) \> 40% of predicted value within 3 months of registration * Forced vital capacity (FVC) \> 40% of predicted value within 3 months of registration * Serum creatinine =\< 1.5 mg/dL (133 mmol/L) * Serum albumin \>= 3.2 g/dL (or \>= 32 g/L) without IV albumin within the previous 72 hours * Bilirubin =\< 1.5 x the upper limit of normal (\[ULN\] except patients with Gilbert syndrome in whom bilirubin level of \> 1.5 x ULN will be allowed) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 times ULN * Hemoglobin \>= 8 g/dL with or without transfusion in the last 7 days * Absolute neutrophil count (ANC) \>= 1000 w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants That Received Planned Tagraxofusp Post Transplant

Timeframe: Up to 1 year

Trial details

NCT IDNCT04317781

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-11

Results submitted2024-06-21

View on ClinicalTrials.gov More Blastic Plasmacytoid Dendritic Cell Neoplasm trials