The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM

Waldenström Macroglobulinemia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844309
• Other study ID #: IIT2015004-EC-2
• Status: Recruiting
• Phase: Phase 4
• First received: July 17, 2016
• Last updated: July 25, 2016
• Start date: May 2016
• Est. completion date: May 2020

Study information

• Verified date: July 2016
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Shuhua Yi, Doc
• Phone: 86-22-23909106
• Email: yishuhua[@]ihcams.ac.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Drug:
• Thalidomide
thalidomide 50-150 mg per night

Locations

Country	Name	City	State
China	Shuhua Yi	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		up to 12 months	No
Secondary	progress-free survival		up to 36 months	No