Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Overview
- Phase
- Phase 4
- Intervention
- autologous stem cell transplantation
- Conditions
- Waldenström Macroglobulinemia
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- progress-free survival
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Yi Shuhua
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, China
Eligibility Criteria
Inclusion Criteria
- •70 years\>=Aged \>=18 years
- •diagnosed with high-risk LPL/WM according to the ISSWM criteria
- •untreated or mild treated without standard regimens
- •suitable for ASCT
- •with life-expectancy more than 3 months.
Exclusion Criteria
- •diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
- •transformed lymphoma
- •liver or renal function lesion unrelated to lymphoma
- •serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
- •HIV positive or active HBV infection or other uncontrolled systematic infection
- •clinical central nervous dysfunction
- •serious surgery within 30 days
- •pregnancy or baby nursing period or un-contracepted child-bearing period woman;
- •allergy to the trail drugs.
Arms & Interventions
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
Intervention: autologous stem cell transplantation
conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Intervention: conventional chemotherapy
Outcomes
Primary Outcomes
progress-free survival
Time Frame: up to 36 months
Secondary Outcomes
- complete remission rate(up to 12 months)