Study of a combination therapy in patients with Waldenstrom Macroglobulinemia and active disease not previously treated

Phase II study to evaluate the safety and the efficacy of rituximab, cyclophosphamide, non-pegylated liposomal doxorubicin, vincristine and prednisolone (R-COMP 14) as front-line therapy for patients with active Waldenstrom Macroglobulinemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002388-25-IT

Enrollment

Registered

2014-01-30

Start date

2014-04-01

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Active and untreated Waldenstrom Macroglobulinemia MedDRA version: 16.1 Level: LLT Classification code 10054693 Term: Von Waldenstrom macroglobulinemia System Organ Class: 100000004864

Interventions

Trade Name: MYOCET Product Name: Myocet Product Code: L01DB Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed informed consent prior to any study procedures being performed • Diagnosis of untreated Waldenstrom Macroglobulinemia • Age >18 and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • People unable or unwilling to give informed consent. • Age 80 years. • HIV positivity. • HCV positivity with high viral load.. • HBs Ag positivity. • Pregnancy or nursing female • Current uncontrolled infection. • Patients with a history of other malignancies within 2 years prior to study entry. • Treatment with any other IMP, or participating in another clinical trial within 30 days prior to entering this study. • Lacking of at least one criteria of active disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the 1-year complete remission (CR) rate;Secondary Objective: • To assess the safety of the R-COMP-14 chemotherapy • To assess the disease-free survival • To assess the overall survival;Primary end point(s): To assess the 1-year complete remission (CR) rate.;Timepoint(s) of evaluation of this end point: 1-year	—

Secondary

Measure	Time frame
Secondary end point(s): • To assess the safety of the R-COMP-14 chemotherapy • To assess the disease-free survival • To assess the overall survival;Timepoint(s) of evaluation of this end point: 2-years	—

Countries

Italy

Contacts

Public ContactAlessandro Isidori

Hematology Clinical Trial Office

alessandro.isidori@ospedalimarchenord.it+390721364022

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026