A Phase 2 interventional study of Tagraxofusp-erzs in Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To evaluate the safety of tagraxofusp-erzs (tagraxofusp) in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) after autologous (auto) or allogeneic (allo) hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. To estimate progression-free survival (PFS) in patients with BPDCN receiving maintenance therapy with tagraxofusp after auto-HCT or allo-HCT.
II. To estimate the overall survival (OS) in patients with BPDCN receiving maintenance therapy with tagraxofusp after auto-HCT or allo-HCT.
OUTLINE:
Within day 45 and 180 after stem cell transplant, patients receive tagraxofusp-erzs intravenously (IV) over 15 minutes on days 1-3 of cycles 1-4 and days 1-2 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 1 year.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Within day 45 and 180 after stem cell transplant, patients receive tagraxofusp-erzs IV over 15 minutes on days 1-3 of cycles 1-4 and days 1-2 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Biological: Tagraxofusp-erzs
Given IV
Also known as: Diphtheria Toxin(388)-Interleukin-3 Fusion Protein, DT(388)-IL3 Fusion Protein, DT388IL3 fusion protein, Elzonris, IL3R-targeting Fusion Protein SL-401, SL-401, Tagraxofusp, Tagraxofusp ERZS
Number of Participants That Received Planned Tagraxofusp Post Transplant
Participants completed at least 75% of planned tagraxofusp doses in at least 4 cycles of therapy.
Time frame: Up to 1 year
Progression Free Survival (PFS)
Participant alive and disease free one year post transplant
Time frame: From treatment start date to date of disease progression or death, assessed up to 1 year
Overall Survival (OS)
Number of participants alive one year post transplant
Time frame: From treatment start date to death, assessed up to 1 year
All participants were registered at MD Anderson Cancer Center
| Milestone | Treatment (Tagraxofusp-erzs) |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Disease relapse | 1 |
| Withdrew: Withdrawal by subject | 1 |
Participants completed at least 75% of planned tagraxofusp doses in at least 4 cycles of therapy.
| Participants | Treatment (Tagraxofusp-erzs) |
|---|---|
| Number of Participants That Received Planned Tagraxofusp Post Transplant | 1 |
Participant alive and disease free one year post transplant
| Participants | Treatment (Tagraxofusp-erzs) |
|---|---|
| Progression Free Survival (PFS) | 2 |
Number of participants alive one year post transplant
| Participants | Treatment (Tagraxofusp-erzs) |
|---|---|
| Overall Survival (OS) | 2 |
Collected over up to a year post transplant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Tagraxofusp-erzs) | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | Treatment (Tagraxofusp-erzs) |
|---|---|
| Elevated TransaminasesInvestigations | 1/3 |
| Age, Categorical(Participants) | Treatment (Tagraxofusp-erzs) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Treatment (Tagraxofusp-erzs) |
|---|---|
| Female | 1 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Treatment (Tagraxofusp-erzs) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Tagraxofusp-erzs) |
|---|---|
| United States | 3 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center