PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
Primary Purpose
Treatment
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
rituximab /Dexamethasone/cyclophosphamide
Velcade/Dexamethasone/cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Treatment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- First Affiliated Hospital, Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rituximab /Dex/CTX
Velcade/Dex/CTX
Arm Description
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/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
Outcomes
Primary Outcome Measures
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
Investigators try to compare the complete remission (CR) rates at the end of the research.
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Secondary Outcome Measures
Full Information
NCT ID
NCT02971982
First Posted
October 19, 2016
Last Updated
November 20, 2016
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT02971982
Brief Title
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
Official Title
Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rituximab /Dex/CTX
Arm Type
Experimental
Arm Description
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
Arm Title
Velcade/Dex/CTX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
rituximab /Dexamethasone/cyclophosphamide
Intervention Description
rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
Intervention Type
Drug
Intervention Name(s)
Velcade/Dexamethasone/cyclophosphamide
Intervention Description
Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg
Primary Outcome Measure Information:
Title
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
Time Frame
2 years
Title
Investigators try to compare the complete remission (CR) rates at the end of the research.
Time Frame
2 years
Title
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
Time Frame
2 years
Title
Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Time Frame
2 yeas
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu cheng cheng, PhD
Phone
86-512-67781856
Email
evergirl@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fu cheng cheng, Phd
Organizational Affiliation
First Affiliated Hospital,Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital, Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu chengcheng, Phd
Phone
13962191404
Email
evergirl@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
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