Prophylaxis of graft-versus-host disease after allogenous blood stem cell transplantation MedDRA version: 9.1 Level: LLT Classification code 10018799 Term: GVHD
Conditions
Interventions
Trade Name: Myfortic 360 mg magensaftresistente Filmtabletten (coated tablets)
Pharmaceutical Form: Gastro-resistant tablet
Other descriptive name: MYCOPHENOLATE SODIUM
Concentration unit: mg milligra
Sponsors
University Medical Centre Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient 1. Disease involves CNS 2. Pulmonary disease with VC 1,5 mg/dl and/or creatinine clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - incidence and severity of the acute GvHD - incidence and severity of the chronic GvHD within 1 year - progression free survival rate 100 days and 1 year after transplantation - overall survival rate 100 days and 1 year after transplantation ;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 | — |
Countries
Germany
Outcome results
None listed