Study of VTD in Waldenstrom's Macroglobulinemia

Phase 2

• Conditions: Lymphoplasmacytic Lymphoma; Waldenstrom Macroglobulinemia
• Interventions: Drug: Bortezomib

• Registration Number: NCT03335098
• Lead Sponsor: Seoul National University Hospital

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 diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Status Verified: 2017-11
• Study First Submitted: 2017-11-04
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Bortezomib	Subcutaneous bortezomib 1.3mg/m2 on days 1, 4, 8, and 11 (every 4 weeks, up to 6 cycles) Oral thalidomide 50mg daily on days 1-28 (every 4 weeks, up to 6 cycles) Intravenous or oral dexamethasone 40mg on days 1-4 (every 4 weeks, up to 6 cycles)

Primary Outcome Measures

Name	Time	Method
Overall response rate	at 3 years	Overall response rate as per Lugano criteria

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	at 3 years	Time from enrollment to disease progression or death from any cause
Overall survival	at 3 years	Time from enrollment to death from any cause

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of