Status:
UNKNOWN
Study of VTD in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Waldenstrom Macroglobulinemia
Lymphoplasmacytic Lymphoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 diagnose...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03335098
Start Date
November 21 2016
End Date
December 1 2020
Last Update
November 7 2017
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
2
Seoul National University Hospital
Seoul, South Korea, 03080