Tagraxofusp in Treating Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm After Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT04317781|
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Blastic Plasmacytoid Dendritic Cell Neoplasm||Biological: Tagraxofusp-erzs||Phase 2|
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).
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.
Within day 45 and 120 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tagraxofusp (SL-401) Therapy for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patients Post-Autologous or Post-Allogeneic Hematopoietic Cell Transplantation|
|Actual Study Start Date :||March 27, 2020|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Treatment (tagraxofusp-erzs)
Within day 45 and 120 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.
- Tolerability of tagraxofusp post-stem cell transplantation (SCT) [ Time Frame: Up to 1 year ]Tolerability is defined as receipt of at least 75% of planned tagraxofusp doses in at least 4 cycles of therapy. The percentage of patients considered 'tolerating' will be presented along with the associated 95% exact confidence interval.
- Progression free survival (PFS) [ Time Frame: From treatment start date to date of disease progression or death, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method. Median PFS as well as rates with corresponding 95% confidence intervals will be presented.
- Overall survival (OS) [ Time Frame: From treatment start date to death, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method. Median OS as well as rates with corresponding 95% confidence intervals will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317781
|Contact: Qaiser Bashirfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Qaiser Bashir 713-792-8750|
|Principal Investigator: Qaiser Bashir|
|Principal Investigator:||Qaiser Bashir||M.D. Anderson Cancer Center|