Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

Waldenström Macroglobulinemia Clinical Trial

— BDH-WM03  

Official title:

Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844361
• Other study ID #: ITT2015006-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 whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

Description:

WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 70 years>=Aged >=18 years

2. diagnosed with high-risk LPL/WM according to the ISSWM criteria

3. untreated or mild treated without standard regimens

4. suitable for ASCT

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

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Other:
• autologous stem cell transplantation
Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
• conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy

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	progress-free survival		up to 36 months	No
Secondary	complete remission rate		up to 12 months	No