Clinical trial · Interventional
The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia
The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China
NCT02844322CI-TRIAL-00102984BDH-WM01completedPhase 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 compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.
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 |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
- interventionNames
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- rituximab
- description
- Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
- interventionNames
- Drug: Rituximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. aged \>=18 years 2. diagnosed with LPL/WM 3. untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib 4. symptom patients 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 (1)
- DERIVEDXiong W, Lyu R, Yu Y, Wang T, Yan Y, Wang Y, Liu W, An G, Deng S, Xu Y, Sui W, Huang W, Zou D, Wang J, Qiu L, Yi S. Rituximab plus cyclophosphamide and dexamethasone versus bortezomib plus cyclophosphamide and dexamethasone in newly diagnosed symptomatic Waldenstrom macroglobulinemia: a randomized controlled trial. Haematologica. 2024 May 1;109(5):1614-1618. doi: 10.3324/haematol.2023.284588. No abstract available. PMID 38205507