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

Phase 1

• Conditions: Active and untreated Waldenstrom Macroglobulinemia; MedDRA version: 16.1Level: LLTClassification code 10054693Term: Von Waldenstrom macroglobulinemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-002388-25-IT
• Lead Sponsor: Azienda Ospedaliera Ospedali Riuniti Marche Nord

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-30
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Signed informed consent prior to any study procedures being performed
• Diagnosis of untreated Waldenstrom Macroglobulinemia
• Age >18 and <80 years.
• Karnofsky score = 70% or WHO =1.
• Adequate renal, pulmonary and hepatic function:
Serum creatinine < 2 mg/dl;
Sat O2 = 96%;
ALT/AST = 2.5 x N.
• Fertile female must use adequate contraceptive precautions.
• Patients with active disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• People unable or unwilling to give informed consent.
• Age < 18 or > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified