Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-10 @ 10:23 AM
Study NCT ID:
NCT02844361
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2016-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Organization:
Study Overview
Official Title:
Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BDH-WM03
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: