PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT02971982
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab /Dexamethasone/cyclophosphamide — DRUG
    rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
  • Velcade/Dexamethasone/cyclophosphamide — DRUG
    Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2016
Primary completion
Oct 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab /Dex/CTX
    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
  • Experimental: Velcade/Dex/CTX
    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 Measure

Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. [ Time Frame: 2 years ]

Central Contacts

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