Patients suffering from leukemia (acute or chronic), receiving allogenic blood stem cell transplantation
Conditions
Interventions
Trade Name: Kepivance 6,25 mg Pulver zur Herstellung einer Injektionslösung
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Palifermin
Concentration unit: mg milligram(s)
Co
Sponsors
GMIHO Gesellschaft für medizinische Innovation/Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age >= 18 years -general condition ECOG WHO =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -contraindication for allogenic stem cell transplantation -dose-reduced conditioning with <= 8 Gy total body irradation dose -haploid stem cell donor -pregnant or lactating women -women of childbearing potential not using a high effective method for contraception -pre-medication with palifermin -hypersensitivity against palifermin, one of its contents or proteins derived from eschericia coli -no signed informed consent of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe the incidence of grade 3 and 4 (WHO) mucositis with or without application of kepivance;Secondary Objective: To observe -the incidence of the ulcerative mucositis (WHO grade 2-4) -duration of WHO grade 3 and 4 mucositis -process of the cellular T-cell reconstitution after transplantation -supportive care necessary (blood cell substitute, pain therapy (opioids necessary), parenteral nutrition -grade and extnt of the acute graft-versus-host disease -interaction with drug-induced immunsupression -rate of infections (number of days with fever, antibiotics needed) -therapy-induced mortalitiy day+100 -number of relapses +360 days after steem cell transplantation -median times to granulocyte engraftment > 1000/µl, to platelet engraftment > 20000/µl and > 50000/µl -rate and duration of febrile episodes -duration of hospitalisation;Primary end point(s): -incidence of grade 3 and 4 (WHO) mucositis | — |
Countries
Germany
Outcome results
None listed