Brief Title
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Official Title
Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
progress-free survival
Secondary Outcome
complete remission rate
Condition
Waldenström Macroglobulinemia
Intervention
autologous stem cell transplantation
Study Arms / Comparison Groups
autologous stem cell transplantation
Description: Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
70
Start Date
May 2016
Completion Date
May 2020
Primary Completion Date
November 2019
Eligibility Criteria
Inclusion Criteria:
1. 70 years>=Aged >=18 years
2. diagnosed with high-risk LPL/WM according to the ISSWM criteria
3. untreated or mild treated without standard regimens
4. suitable for ASCT
5. with life-expectancy more than 3 months.
Exclusion Criteria:
1. diagnosed with other malignancies outside B-NHL within one year(including active
center neural system lymphoma)
2. transformed lymphoma
3. liver or renal function lesion unrelated to lymphoma
4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious
angiocardiopathy determined by the physician
5. HIV positive or active HBV infection or other uncontrolled systematic infection
6. clinical central nervous dysfunction
7. serious surgery within 30 days
8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9.
allergy to the trail drugs.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Shuhua Yi, Doc, 86-22-23909106, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02844361
Organization ID
ITT2015006-EC-2
Responsible Party
Principal Investigator
Study Sponsor
Institute of Hematology & Blood Diseases Hospital
Study Sponsor
Shuhua Yi, Doc, Principal Investigator, blood disease hospital, Chinese Academic Medical School
Verification Date
July 2016