Brief Title
The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Overall response rate
Secondary Outcome
progress-free survival
Condition
Waldenström Macroglobulinemia
Intervention
Thalidomide
Study Arms / Comparison Groups
Thalidomide
Description: thalidomide 50-150mg per night
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
Drug
Estimated Enrollment
44
Start Date
May 2016
Completion Date
May 2020
Primary Completion Date
November 2019
Eligibility Criteria
Inclusion Criteria:
1. Aged >=18 years
2. diagnosed with WM
3. Untreated or mild treated without standard regimens,especially untreated with
rituximab and/or bortezomib
4. symptom patients
5. with life-expectancy more than 3 months.
Exclusion Criteria:
1. diagnosed with other malignancies outside B-NHL within one year(including active
centre 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 - 85 Years
Accepts Healthy Volunteers
No
Contacts
Shuhua Yi, Doc, 86-22-23909106, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02844309
Organization ID
IIT2015004-EC-2
Responsible Party
Principal Investigator
Study Sponsor
Institute of Hematology & Blood Diseases Hospital
Study Sponsor
Shuhua Yi, Doc, Principal Investigator, institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Verification Date
July 2016