Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
NCT ID: NCT02844361
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2016-05-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
conventional chemotherapy
Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Principal Investigators
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Shuhua Yi, Doc
Role: PRINCIPAL_INVESTIGATOR
blood disease hospital, Chinese Academic Medical School
Locations
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Shuhua Yi
Tianjin, , China
Countries
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Other Identifiers
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IIT2015006
Identifier Type: -
Identifier Source: org_study_id
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