Patients with acute leukemia with an indication for allogeneic HCT but without a suitable HLA-identical donor
Conditions
Interventions
Product Name: CD3/CD19 depleted stem cells
Pharmaceutical Form: Intravenous infusion
Sponsors
Uniklinikum Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with either ALL or AML being in CR with an indication for allogeneic HCT* but without a suitable HLA-identical donor** within an acceptable time period or with relapse after a preceding allogeneic HCT from an HLA-identical donor • Age 18 years • Karnofsky Index >60% ** AML: high risk patients with one or more of the following risk factors: FLT-3 mutation Complex cytogenetics abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p) Late CR > induction I Age >60 Patients in 2.CR Secondary AML ALL: high risk patients with one or more of the following risk factors: Pro-B-ALL Inital WBC >30.000/µL CR after day 46 after Induction II Complex cytogenetics, t(9,22), t(4,11) Early or mature T-ALL Initially refractory patients with late CR Rising MRD level Patients in 2. CR * As acceptable HLA-identical donor not more than 1 antigen mismatch (9/10-Match) or more than 2 allelic mismatches by high-resolution typing are allowed. Critical cases should be discussed with the PI 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
Exclusion criteria
Exclusion criteria: • Patients with >5% blasts in BM at the time of transplantation • Less than 3 months after preceding HCT • CNS involvement with disease • History of neurologic impairment such as: seizures, severe peripheral neuropathy, signs of leukencephalopathy, CNS infection, multiple intrathecal chemotherapies, CNS irradiation. In case of heavy preatreatment with irradiation or intrathecal chemotherapy pretransplant CNS MRI and neurological consultation are mandatory • 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 <50 ml/min • Respiratory failure necessitating supplemental oxygen or DLCO <30% • Allergy against murine antibodies • 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: • Evaluation of treatment related mortality, toxicity and engraftment after haploidentical HCT;Secondary Objective: • Evaluation of disease response, overall- and disease free survival • Evaluation of the incidence and severity of graft versus host disease • Evaluation of the incidence and severity of bacterial, viral or fungal infections • Evaluation of the immune reconstitution after haploidentical HCT ;Primary end point(s): Evaluation of treatment related mortality, toxicity and engraftment after haploidentical HCT | — |
Countries
Germany
Outcome results
None listed