Back to resultsThe Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia (BDH-WM01)
Primary Purpose
Waldenström Macroglobulinemia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Waldenström Macroglobulinemia
Eligibility Criteria
Inclusion Criteria:
- aged >=18 years
- diagnosed with LPL/WM
- untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
- symptom patients
- 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
Experimental
Arm Label
Bortezomib
rituximab
Arm Description
Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
progress-free survival
Full Information
NCT ID
NCT02844322
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
NCT02844322
Brief Title
The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia
Acronym
BDH-WM01
Official Title
The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control 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 compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.
Detailed Description
Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström Macroglobulinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib
Arm Type
Experimental
Arm Description
Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Arm Title
rituximab
Arm Type
Experimental
Arm Description
Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
velcade
Intervention Description
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
progress-free survival
Time Frame
up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged >=18 years
diagnosed with LPL/WM
untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib
symptom patients
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
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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
we will make the data publicly available according to the local law
Learn more about this trial
The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia
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