Multicenter Study of Peritransplantation Immunosuppression for Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning

Prof. Dr. med. Wolfgang Bethge

Status and phase

Terminated

Phase 2

Conditions

Patients Receiving Mismatched Allogeneic HCT

Treatments

Drug: immunosuppression

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01582048

E:531/2011

2011-002192-41 (EudraCT Number)

Details and patient eligibility

About

Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus, mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a reduced intensity conditioning regimen with fludarabine/treosulfan

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for mismatched allogeneic HCT
Unrelated donor with maximal 2 antigen or allelic mismatches in HLA-I or HLA-II
Age >=75, >=18 years
Patients Age <=50 if a HCT-CI score > 2 [acc. to Sorror et al., 2005]
Karnofsky Index >60%
Patients with:
- Acute myeloid leukemia in CR (<5% blasts)
- Acute lymphoblastic leukemia in CR (< 5% blasts)
- Myelodysplastic syndrome with up to 20% blasts
- Osteomyelofibrosis
- Chronic lymphocytic leukemia
- High grade Non-Hodgkin Lymphoma in CR or PR
- Low grad Non-Hodgkin Lymphoma in CR or PR
- M. Hodgkin in CR or PR
- Chronic myeloid leukaemia in chronic phase or CR of blast crisis

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 <40 % on echocardiography
Patients with > grade II hypertension by CTC criteria
Creatinine clearance <50 ml/min
Proteinuria >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