Treatment of patient with advanced hematologic malignancies such as patients with leukemia or lymphoma treatable by allogeneic stem cell transplantation but without a suitable matched donor.
Conditions
Interventions
Trade Name: CellCept
Product Name: CellCept
Pharmaceutical Form: Tablet
CAS Number: 115007-34-6
Other descriptive name: MYCOPHENOLATE MOFETIL
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients scheduled for mismatched allogeneic HCT • Unrelated donor with maximal 2 antigen or allelic mismatches in HLA-I or HLA-II • Age lower or equal 75, higher or equal 18 years • Patients Age below 50 if a HCT-CI score > 2 [acc. to Sorror et al., 2005] • Karnofsky Index >60% • Patients with: Acute myeloid leukaemia in CR (=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Patients with >5% blasts in BM at the time of transplantation • Progressive or chemorefractory disease • Less than 3 months after preceding HCT • CNS involvement with disease • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month. • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal. • Chronic active viral hepatitis • Ejection fraction grade II hypertension by CTC criteria • Creatinine clearance 800 mg/24 h • Respiratory failure necessitating supplemental oxygen or DLCO <30% • Allergy against murine antibodies • Known allergy/intolerance against sirolimus or one of it’s excipients • HIV-Infection • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry) • Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction) • Patients unwilling or unable to comply with the protocol • Unable to give informed consent • Enrollment in an other trial interfering with the endpoints of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment related mortality 12 and 24 months after HCT.;Secondary Objective: Toxicity of protocol on day 100 Engraftment on day 100 Overall- and disease free survival, disease response 12 and 24 months after HCT Incidence and severity of graft versus host disease 3, 6, 12 and 24 months after HCT Incidence and severity of bacterial, viral or fungal infections Immune reconstitution 3, 6, 12 and 24 months after HCT;Primary end point(s): Treatment related mortality;Timepoint(s) of evaluation of this end point: 12 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity of protocol on day 100 Engraftment on day 100 Overall- and disease free survival, disease response 12 and 24 months after HCT Incidence and severity of graft versus host disease 3, 6, 12 and 24 months after HCT Incidence and severity of bacterial, viral or fungal infections Immune reconstitution 3, 6, 12 and 24 months after HCT ;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Germany
Contacts
Public ContactProfessor Wolfgang A. Bethge
University Hospital Tübingen
Outcome results
None listed