Back to resultsComparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia (BDH-WM03)
Primary Purpose
Waldenström Macroglobulinemia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
autologous stem cell transplantation
conventional chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Waldenström Macroglobulinemia focused on measuring high-risk, ASCT
Eligibility Criteria
Inclusion Criteria:
- 70 years>=Aged >=18 years
- diagnosed with high-risk LPL/WM according to the ISSWM criteria
- untreated or mild treated without standard regimens
- suitable for ASCT
- with life-expectancy more than 3 months.
Exclusion Criteria:
- diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
- transformed lymphoma
- liver or renal function lesion unrelated to lymphoma
- serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
- HIV positive or active HBV infection or other uncontrolled systematic infection
- clinical central nervous dysfunction
- serious surgery within 30 days
- pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.
Sites / Locations
- Shuhua YiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
autologous stem cell transplantation
conventional chemotherapy
Arm Description
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Outcomes
Primary Outcome Measures
progress-free survival
Secondary Outcome Measures
complete remission rate
Full Information
NCT ID
NCT02844361
First Posted
July 17, 2016
Last Updated
July 25, 2016
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02844361
Brief Title
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Acronym
BDH-WM03
Official Title
Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström Macroglobulinemia
Keywords
high-risk, ASCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
autologous stem cell transplantation
Arm Type
Experimental
Arm Description
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Arm Title
conventional chemotherapy
Arm Type
Active Comparator
Arm Description
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Intervention Type
Other
Intervention Name(s)
autologous stem cell transplantation
Intervention Description
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
Intervention Type
Other
Intervention Name(s)
conventional chemotherapy
Intervention Description
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Primary Outcome Measure Information:
Title
progress-free survival
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
complete remission rate
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
70 years>=Aged >=18 years
diagnosed with high-risk LPL/WM according to the ISSWM criteria
untreated or mild treated without standard regimens
suitable for ASCT
with life-expectancy more than 3 months.
Exclusion Criteria:
diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
transformed lymphoma
liver or renal function lesion unrelated to lymphoma
serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
HIV positive or active HBV infection or other uncontrolled systematic infection
clinical central nervous dysfunction
serious surgery within 30 days
pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuhua Yi, Doc
Phone
86-22-23909106
Email
yishuhua@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lugui Qiu, Doc
Phone
86-22-23909172
Email
qiulg@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi, Doc
Organizational Affiliation
blood disease hospital, Chinese Academic Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuhua Yi
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi, Doc
Phone
86-22-23909106
Email
yishuhua@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, Doc
Phone
86-22-23909172
Email
qiulg@ihcams.ac.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
dependent on the local law
Learn more about this trial
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
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