Trial Outcomes & Findings for Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant (NCT NCT04317781)

NCT ID: NCT04317781

Last Updated: 2024-07-31

Results Overview

Participants completed at least 75% of planned tagraxofusp doses in at least 4 cycles of therapy.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2024-07-31

Participant Flow

All participants were registered at MD Anderson Cancer Center

Participant milestones

Measure	Treatment (Tagraxofusp-erzs) 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. Tagraxofusp-erzs: Given IV
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Treatment (Tagraxofusp-erzs) 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. Tagraxofusp-erzs: Given IV
Overall Study Adverse Event	1
Overall Study Disease relapse	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment (Tagraxofusp-erzs) n=3 Participants 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. Tagraxofusp-erzs: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Participants completed at least 75% of planned tagraxofusp doses in at least 4 cycles of therapy.

Outcome measures

Measure	Treatment (Tagraxofusp-erzs) n=3 Participants 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. Tagraxofusp-erzs: Given IV
Number of Participants That Received Planned Tagraxofusp Post Transplant	1 Participants

SECONDARY outcome

Timeframe: From treatment start date to date of disease progression or death, assessed up to 1 year

Participant alive and disease free one year post transplant

Outcome measures

Measure	Treatment (Tagraxofusp-erzs) n=3 Participants 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. Tagraxofusp-erzs: Given IV
Progression Free Survival (PFS)	2 Participants

SECONDARY outcome

Timeframe: From treatment start date to death, assessed up to 1 year

Number of participants alive one year post transplant

Outcome measures

Measure	Treatment (Tagraxofusp-erzs) n=3 Participants 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. Tagraxofusp-erzs: Given IV
Overall Survival (OS)	2 Participants

Adverse Events

Treatment (Tagraxofusp-erzs)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Tagraxofusp-erzs) n=3 participants at risk 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. Tagraxofusp-erzs: Given IV
Investigations Elevated Transaminases	33.3% 1/3 • Number of events 1 • up to a year post transplant

Additional Information

Qaiser Bashir, M.D. / Stem Cell Transplantation and Cellular Therapy Department

The University of Texas MD Anderson Cancer Center

Phone: 713-794-4422

Email: qbashir@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place