PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
- Conditions
- Treatment
- Interventions
- Drug: Velcade/Dexamethasone/cyclophosphamide
- Registration Number
- NCT02971982
- Brief Summary
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
- Detailed Description
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Recently diagnosed WM according to the second 2002 WM international working group
- Not previously treated, apart from not regularly received by Chlorambucil
- Aged from 18 to 75 years, both male and female
- Ability to give signed informed consent
- Negative pregnancy test at inclusion (if necessary)
- ECOG from 0 to 2
- Known hypersensitivity to rituximab or velcade or cyclophosphamide
- Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
- Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above
- Positive HIV serology
- Serious psychiatric item in the history
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rituximab /Dex/CTX rituximab /Dexamethasone/cyclophosphamide rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28 Velcade/Dex/CTX Velcade/Dexamethasone/cyclophosphamide Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28
- Primary Outcome Measures
Name Time Method Investigators try to compare the complete remission (CR) rates at the end of the research. 2 years Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. 2 years Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research. 2 yeas Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research. 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
First Affiliated Hospital, Soochow University
🇨🇳Suzhou, Jiangsu, China