MedTrace Logo

Randomised Trial in Waldenstrom's Macroglobulinaemia

NCT01592981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-18

No results posted yet for this study

Summary

The purpose of this trial is to assess tolerability and efficacy of the Bortezomib, Cyclophosphamide and Rituximab combination as initial therapy for previously untreated patients with symptomatic Waldenstrom's macroglobulinaemia.

Conditions

  • Waldenstrom's Macroglobulinaemia

Interventions

DRUG

Bortezomib

1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle

DRUG

Cyclophosphamide

Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm. Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm.

BIOLOGICAL

Rituximab

Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only

DRUG

Fludarabine

Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Rebecca Auer · St. Bartholomew's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-03-31
Completion
2020-08-02

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01592981 on ClinicalTrials.gov