Study of VTD in Waldenstrom's Macroglobulinemia

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Seoul National University Bundang Hospital
• Treatments: Bortezomib; Dexamethasone; Thalidomide

Criteria

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