The efficientcy of thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintaince therapy for the newly diagnosed Waldenstr?m macroglobulinemia - a Prospective Multicentre Phase III Trial from China

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OIC-16008402
• Date of registration: 2016-05-01
• Prospective Registration: Yes
• Primary sponsor: Institute of Hematology Blood Disease Hospital, Chinese Academy of Medical Sciences Peking Union Medical College
• Public title: The efficientcy of thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintaince therapy for the newly diagnosed Waldenstr?m macroglobulinemia - a Prospective Multicentre Phase III Trial from China
• Scientific title: The efficientcy of thalidomide plus cyclophosphamide and dexamethasone following by thalidomide and prednisone maintaince therapy for the newly diagnosed Waldenstr?m macroglobulinemia - a Prospective Multicentre Phase III Trial from China
• Date of first enrolment: 2016-05-01
• Target sample size: 1:44;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=14223
• Study type: Observational study
• Study design: Case series
• Phase: III (Phase III study)

Countries of recruitment

China

Contacts

• Name: Shuhua Yi
• Affiliation: Institute of Hematology Blood Disease Hospital, Chinese Academy of Medical Sciences Peking Union Medical College

• Name: Shuhua Yi
• Affiliation: Institute of Hematology Blood Disease Hospital, Chinese Academy of Medical Sciences Peking Union Medical College

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged >=18 years;
2. diagnosed with LPL/WM;
3. Untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortizomib;
4. symptom patients;
5. with life-expectary 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 funcation lesion unrelated to lymphoma;
4. serious complications such as uncontroled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician;
5. HIV positive or active HBV infection or other uncontroled systematic infection;
6. clincial central nervous dysfunction;
7. serious surgery within 30 days;
8. pregnancy or baby nursing period or uncontracept child-bearing period woman;
9. allergy to the trail drugs.

Age minimum: 18
Age maximum: 85
Gender: Both

Health Condition(s) or Problem(s) studied

lymphoplasmacytic lymphoma / Waldenstrom macroglobulinemia

Intervention(s)

1:chemotherapy;

Primary Outcome(s)

overall response rate;

Secondary Outcome(s)

complete remission rate;

Source(s) of Monetary Support

State Science Technology Project in China