Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Waldenström Macroglobulinemia

Intervention / Treatment
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* Other: autologous stem cell transplantation
* Other: conventional chemotherapy


Participation Criteria
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Eligibility Criteria
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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; 9. allergy to the trail drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous stem cell transplantation<br>Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback | Other: autologous stem cell transplantation<br>* Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback<br>|
| Active Comparator: conventional chemotherapy<br>Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy | Other: conventional chemotherapy<br>* Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress-free survival |  | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-risk, ASCT