Feasibility of extracorporeal elimination of liposomal chemotherapeutics by double membrane plasmapheresis

Feasibility of extracorporeal elimination of liposomal chemotherapeutics by double membrane plasmapheresis - CARL-Studie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000163

Enrollment

Registered

2009-07-15

Start date

2010-06-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C50 C56

Interventions

Group 1: Day 1 Navelbine 25 mg/m2 i.v. Day 8 Navelbine 25 mg/m2 i.v Day 15 Caelyx 40 mg/m2 i.v. Day 17 Plasmapherese (Membranfiltration) 3l Plasmavolumen 4q3 wks or day 1 50 mg/m2 Caelyx, day 3 Pla

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: -primary breast cancer -age 18<x<60 -ECOG performance status <2 -secure vein access for apheresis catheter possible

Exclusion criteria

Exclusion criteria: -Creatinin clearance =NYHA II -Hemoglobin < 10 g/dl; neutrophiles < 1500/µl; thrombocytes < 100.000/µl -allergic reaction to navelbine, doxorubicin, liposomal doxorubicin, heparin -skin disease -BMI < 20 -pregnancy -prior treatment with Doxil/Caelyx -regular extracorporeal treatments -treatment with ACE-inhibitors or AT-1- receptorantagonists

Design outcomes

Primary

Measure	Time frame
Efficacy and safety of extracorporeal elimination of liposomal chemotherapeutics by double membrane plasmapheresis	—

Secondary

Measure	Time frame
Occurence of main severe side effects (PPE, Stomatitis, Neutropenia) quality of life	—

Countries

Germany

Contacts

Public ContactOliver Schmah

Uniklinik Freiburg Abt. Hämatologie und Onkologie

oliver.schmah@uniklinik-freiburg.de01718371630

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 28, 2026