Clinical trial · Interventional
Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
NCT02844361CI-TRIAL-00103081BDH-WM03completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenström Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous stem cell transplantation | Procedure | — | UNRESOLVED |
| conventional chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- autologous stem cell transplantation
- description
- Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
- interventionNames
- Procedure: autologous stem cell transplantation
- type
- ACTIVE_COMPARATOR
- label
- conventional chemotherapy
- description
- Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
- interventionNames
- Drug: conventional chemotherapy
Primary outcomes (1)
- measure
- progress-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.