Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04317781

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

Blastic Plasmacytoid Dendritic Cell Neoplasm Clinical Trial

Official title:
Tagraxofusp (SL-401) Therapy for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patients Post-Autologous or Post-Allogeneic Hematopoietic Cell Transplantation

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Neoplasms
Clinical Trial Details
NCT number NCT04317781
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date March 27, 2020
Completion date July 11, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03246906 - Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation Phase 2
Recruiting NCT04216524 - Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm Phase 2
Completed NCT00397579 - DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes Phase 1/Phase 2
Terminated NCT03075553 - Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Phase 2
Recruiting NCT03113643 - SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Phase 1
Recruiting NCT06013423 - Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases Phase 2
Recruiting NCT05362773 - A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Completed NCT02859623 - Descriptive Study of the Efficacy of Treatments for Blastic Dendritic Cell Neoplasm (BPDCN) N/A
Completed NCT01231919 - MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia Phase 1
Active, not recruiting NCT03386513 - Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN Phase 1/Phase 2
Completed NCT02652715 - Salvia Hispanica Seed in Reducing Risk of Disease Recurrence in Patients With Non-Hodgkin Lymphoma N/A
Active, not recruiting NCT03404193 - Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome Phase 2
Active, not recruiting NCT02220985 - Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD Phase 2
Completed NCT00014235 - Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies N/A
Active, not recruiting NCT02159495 - Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm Phase 1
Recruiting NCT03779854 - Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant Phase 2
Active, not recruiting NCT03485547 - Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Phase 1
Completed NCT02730312 - PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies Phase 1
Completed NCT03974971 - Blastic Plasmacytoid Dendritic Cell Neoplasm in Korean Population.