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

NCT ID: NCT02971982

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

rituximab /Dexamethasone/cyclophosphamide

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Velcade/Dexamethasone/cyclophosphamide

Intervention Type DRUG

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

Interventions

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rituximab /Dexamethasone/cyclophosphamide

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

Intervention Type DRUG

Velcade/Dexamethasone/cyclophosphamide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fu cheng cheng, Phd

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital,Soochow University

Locations

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First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu cheng cheng, PhD

Role: CONTACT

Phone: 86-512-67781856

Email: [email protected]

Facility Contacts

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Fu chengcheng, Phd

Role: primary

Other Identifiers

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myeloma-02

Identifier Type: -

Identifier Source: org_study_id