Clinical trial NCT02971982: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Treatment
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
timeFrame: 2 years
measure: Investigators try to compare the complete remission (CR) rates at the end of the research.
timeFrame: 2 years
measure: Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
timeFrame: 2 years
measure: Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
timeFrame: 2 yeas
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital, Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital,Soochow University
name: Fu cheng cheng, Phd
role: PRINCIPAL_INVESTIGATOR
References: