Waldenstrom Macroglobulinemia Clinical Trial
— BOMB-THROWOfficial title:
A Phase 2 Study to Evaluate the Efficacy of Bortezomib in Patients With De-novo Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma
This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Age of 19 or older - Newly diagnosed Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma - Previously untreated with chemotherapy - ECOG performance status of 2 or lesser - Peripheral blood white blood cell count = 3,500/uL - Peripheral blood neutrophil count = 1,000/uL - Peripheral blood platelet count = 20,000/uL - Peripheral blood hemoglobin = 6.0g/dL - Serum total bilirubin = 2.0 mg/dL - Serum aspartate aminotransferase = 2.5 x (upper normal limit) - Serum alanine aminotransferase = 2.5 x (upper normal limit) Exclusion Criteria: - Diagnosed with other malignancy within 5 years before enrollment - Prior hematopoietic stem cell transplantation - Prior organ transplantation - Uncontrolled central nervous system involvement - Congenital immunodeficiency - Acquired immune deficiency syndrome (AIDS) - Pregnancy - Uncontrolled epilepsy - Uncontrolled psychological disease - Peripheral neuropathy of grade 3 or higher |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate | Overall response rate as per Lugano criteria | at 3 years | |
Secondary | Progression-free survival | Time from enrollment to disease progression or death from any cause | at 3 years | |
Secondary | Overall survival | Time from enrollment to death from any cause | at 3 years |
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