The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

Waldenström Macroglobulinemia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844322
• Other study ID #: IIT2015005-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 compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• 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 LPL/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 center 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Drug:
• Bortezomib
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
• Rituximab
compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

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