Back to resultsThe Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM (BDH-WM02)
Primary Purpose
Waldenström Macroglobulinemia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Waldenström Macroglobulinemia
Eligibility Criteria
Inclusion Criteria:
- Aged >=18 years
- diagnosed with 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 centre 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;
- allergy to the trail drugs.
Sites / Locations
- Shuhua YiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thalidomide
Arm Description
thalidomide 50-150mg per night
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
progress-free survival
Full Information
NCT ID
NCT02844309
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
NCT02844309
Brief Title
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM
Acronym
BDH-WM02
Official Title
The Efficacy of Thalidomide Plus Cyclophosphamide and Dexamethasone Following by Thalidomide and Prednisone Maintenance Therapy for the Newly Diagnosed 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 the efficiency of an oral regimen in newly diagnosed Waldenström macroglobulinemia: thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintenance therapy.
Detailed Description
Enrolled patients will accept maximum 8 cycles of thalidomide plus cyclophosphamide and dexamethasone. if a partial remission response or better is achieved, thalidomide plus prednisone maintenance therapy will be given for no more than two years.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thalidomide
Arm Type
Experimental
Arm Description
thalidomide 50-150mg per night
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thal
Intervention Description
thalidomide 50-150 mg per night
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 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 centre 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;
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
whether to publish primary data is dependent on the local law
Learn more about this trial
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM
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