Everolimus and mycophenolate as GvHD-prophylaxis in the allogenous blood stem cell transplantation(Everolimus und Mycophenolsäure alsGvHD-Prophylaxe in der allogenen Blutstammzelltransplantation) - GvHD Prophylaxis
- Conditions
- Prophylaxis of graft-versus-host disease after allogenous blood stem cell transplantationMedDRA version: 9.1Level: LLTClassification code 10018799Term: GVHD
- Registration Number
- EUCTR2007-001892-12-DE
- Lead Sponsor
- niversity Medical Centre Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patient
1.Acute myeloid leukemia (AML), not curable by chemotherapy alone; patient with CR1, = CR2, primary refractory, with relapse
2.Chronic myeloid leukemia (CML) in chronic phase, if no response to imatinib is documented; in acceleration or blast crisis
3.Myelodysplastic yyndromes (MDS) in the advanced stages RA, RARS (transfusions required), RAEB, RAEB-t and CMML.
4.Lymphomas that require further treatment after standard primary and relapse therapy erneut:
? Plasmocytoma
? Immunocytoma (M. Waldenström)
? Chronic lymphatic leukemia (CLL)
? follicular and highly malignant Non-Hodgkin lymphoma
5.Morbus Hodgkin
6.Karnofsky scale > 60 %
7.Compatibility of matched family or matched unrelated donor (HLA-A-, -B-, -DRB1-Kompatibilität)
8.Written informed consent
Donor:
1.Age < 75 years
2.No suspicion in health status and laboratory
3.Informed consent to G-CSF intake and leukapharesis and implantation of temporary central venous catheters
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) no
F.1.3.1 Number of subjects for this age range
Patient
1. Disease involves CNS
2. Pulmonary disease with VC < 55%, DLCO < 40%
3. Cardiac ejection fraction < 30%, uncontrolled malignant arrhythmia
4. creatinine > 1,5 mg/dl and/or creatinine clearance < 30 ml/min
5. Bilirubine > 2 mg/dl
6. Florid systemic infection (esp. hepatitis B or C)
7. Sero-positive patient for HIV
8. Pregnancy and lactation
9. Women of child bearing potential without sufficient contrazeption
10. Participation in a clinical trial within the last 30 days prior to this study and/or simultaneous participation in another clinical trial for evaluation of pharmaceutical products. The participation in studies with epidemiological objectives or investigations of diagnostic or supportive procedures is allowed as far as they do not interfere with the objectives of this trial.
11. Known drug or alcohol abusus
12. Patient who is not able to give informed consent
13. Hypersensitivity against everolimus, sirolimus or against one of the other ingredients of certican(r) tablets (butylhydroxytoluol, magnesia-stearat, lactose-monohydrate, hypromellose, crospovidone, lactose)
14. Hypersensitivity against mycophenolate-mophetil, mycophenolate, mycophenolate-sodium or against one of the other ingredients of myfortic(r) film tablets (cornstarch, povidone, silicium-dioxide, hypromellosephthalat,e titandioxide [E 171], ferrum(III)-hydroxide-oxide [E 172], indigocarmine [E 132], ferrum(III)-oxide [E 172]
15. Vaccination with attenuated live vaccine within the last 30 days
16. Hereditary disease (e.g. galactose intolerance, Lapp-lactase-lack, glucose-galactose-malabsorption, lack of hypoxanthine-guanine-phosphsribosyl-transferase [e.g. Lesch-Nyhan- and Kelley-Seegmiller-syndrome])
17. Hypersensitivity against mycophenolatmophetil and alemtuzumab
18. active tumor disease
19. uncontrolled ischemic heart disease
Donor:
1. Pregnancy
2. Sero-positive patient for HIV or Hbs antigen
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of therapy associated toxicity of the IMPs wihin 100 days and within 1 year after allogenous blood stem cell transplantation;Secondary Objective: - evaluation of teh hematopoetic engraftment at day 30 after transplantation<br>- incidence and severity of the acute GvHD<br>- incidence and severity of the chronic GvHD within 1 year<br>- progression free survival rate 100 days and 1 year after transplantation<br>- overall survival rate 100 days and 1 year after transplantation<br>;Primary end point(s): Evaluation of therapy associated toxicity of the IMPs wihin 100 days and within 1 year after allogenous blood stem cell transplantation
- Secondary Outcome Measures
Name Time Method