Clinical Trials Logo

Clinical Trial Summary

This study is being done to examine the safety and effectiveness of loncastuximab tesirine as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The name of the study drug involved in this study is: - Loncastuximab tesirine


Clinical Trial Description

This is a single-arm, open-label, phase II study to evaluate the safety and efficacy of loncastuximab tesirine in patients with Waldenström Macroglobulinemia (WM) who have received at least 2 prior treatments, including an anti-CD20 antibody such as rituximab and a BTK inhibitor such as ibrutinib. The U.S. Food and Drug Administration (FDA) has not approved loncastuximab tesirine for Macroglobulinemia (WM) but it has been approved for other uses. Loncastuximab tesirine is a type of therapy called an antibody drug conjugate. This type of treatment is an antibody to CD19, a protein that is typically found on B-cells and plasma cells in patients with Macroglobulinemia (WM). This is a targeted therapy that uses an antibody (immunoglobulin) to deliver a toxin directly to the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 36 people will take part in this research study. ADC Therapeutics is supporting this research study by providing funding and the study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05190705
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Shayna Sarosiek, MD
Phone 617-632-6092
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date June 2022
Completion date August 1, 2027

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Recruiting NCT03630042 - Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia Phase 2
Recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT04062448 - A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) Phase 2
Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Recruiting NCT03679455 - A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1 Phase 2
Not yet recruiting NCT04830046 - Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT01093586 - Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 2
Active, not recruiting NCT03620903 - Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia Phase 2
Not yet recruiting NCT04702932 - Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies
Active, not recruiting NCT03133221 - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Phase 2
Not yet recruiting NCT05003141 - PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies Phase 1
Completed NCT00777738 - Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia Phase 2
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00438880 - Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT00075478 - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 3
Recruiting NCT01272817 - Nonmyeloablative Allogeneic Transplant N/A
Recruiting NCT04116437 - Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment Phase 2
Terminated NCT01416428 - Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies Phase 1/Phase 2