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

Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02971982

Enrollment

Registered

2016-11-23

Start date

2016-10-31

Completion date

2018-12-31

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGrituximab /Dexamethasone/cyclophosphamide

rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg

DRUGVelcade/Dexamethasone/cyclophosphamide

Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.	2 years
Investigators try to compare the complete remission (CR) rates at the end of the research.	2 years
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) 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

Countries

China

Contacts

Primary ContactFu cheng cheng, PhD

evergirl@sina.com86-512-67781856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026