Prospektive, offene, randomisierte, multizentrische Studie zur Effektivität von Palifermin in der Prophylaxe der Mukositis nach allogener Stammzelltransplantation mit myeloablativer Granzkörperbestrahlung
- Conditions
- Patients suffering from leukemia (acute or chronic), receiving allogenic blood stem cell transplantation
- Registration Number
- EUCTR2006-003683-54-DE
- Lead Sponsor
- GMIHO Gesellschaft für medizinische Innovation/Hämatologie und Onkologie mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-age >= 18 years
-general condition ECOG WHO <=2
-life expectancy over three months
-total body irradiation with 10 to 12 Gy total body dosis with a lung dosis of 8 Gy fractionated, in combination with high dose chemotherapy (120 mg/kg body weight cyclophosphamid i.v.)and optional for unrelated donors administration of antithymocyte globulin before application of the graft
-allogeneic stem cell transplantation (bone marrow or blood stem cells) with al HLA-compatible donor with a minimum of 8 out of 10 compatible HLA-class-I (A,B,C) or -II
(DR,DQ) compatibility
-acute or chronic leukemia with an indication for an allogenic stem cell transplantation
-graft-versus-host prophylaxis with cyclosporin A or tacrolismus in a combination with or without mycophenolat or methotrexat
-women of childbearing potential must us an high effictive method for contraception
-negativ pregnancy test
-signed informed consent of the patient
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe the incidence of grade 3 and 4 (WHO) mucositis with or without application of kepivance;Secondary Objective: To observe<br>-the incidence of the ulcerative mucositis (WHO grade 2-4)<br>-duration of WHO grade 3 and 4 mucositis<br>-process of the cellular T-cell reconstitution after transplantation<br>-supportive care necessary (blood cell substitute, pain therapy (opioids necessary), parenteral nutrition<br>-grade and extnt of the acute graft-versus-host disease<br>-interaction with drug-induced immunsupression<br>-rate of infections (number of days with fever, antibiotics needed)<br>-therapy-induced mortalitiy day+100<br>-number of relapses +360 days after steem cell transplantation<br>-median times to granulocyte engraftment > 1000/µl, to platelet engraftment > 20000/µl and > 50000/µl<br>-rate and duration of febrile episodes<br>-duration of hospitalisation;Primary end point(s): -incidence of grade 3 and 4 (WHO) mucositis
- Secondary Outcome Measures
Name Time Method