NCT02844361

Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

Detailed description

WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Conditions

• Waldenström Macroglobulinemia

Interventions

Type	Name	Description
PROCEDURE	autologous stem cell transplantation	Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
DRUG	conventional chemotherapy	Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-11-01
• Completion: 2020-05-01
• First posted: 2016-07-26
• Last updated: 2026-02-11

Locations

1 site across 1 country: China