High-risk haematological malignancies (including AML, ALL, CML, NHL, HD, and MDS) with an indication for allogeneic haematopoietic stem cell transplantation, to support haematopoietic reconstitution following myeloablative therapy. Neoplasias hematológicas de alto riesgo (incluyendo LMA, LLA, LMC, SMD, EH y LNH), con indicación de transplante de líneas celulares hematopoyéticas alogénicas como apoyo para la reconstitución hematopoyética tras el tratamiento mielosupresor. MedDRA version: 9.1 Le
Conditions
Interventions
Product Name: StemEx
Pharmaceutical Form: Intravenous infusion
Other descriptive name: Allogeneic ex vivo expanded umbilical cord blood cells
Concentration type: range
Concentration number: 2.3x10^6 -
Sponsors
Gamida Cell-Teva Joint Venture Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Subject is a candidate for allogeneic myeloablative SCT for treatment of one of the following haematologic malignancies: a.1 Clinical diagnosis of AML: CR2 or subsequent complete remission (CR) or CR1 with high-risk features including any of the following: stem cell or biphenotypic classification (AML-M0), erythroleukemia (AML-M6), acute megakaryocytic leukemia (AML-M7), high-risk cytogenetics, or failure to achieve CR after standard induction therapy or presentation with extramedullary disease or relapse with =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except Hydroxyurea). b. HIV positive. c. Pregnancy or lactation. d. Uncontrolled bacterial, fungal or viral infection. e. Subjects with signs and symptoms of active central nervous system (CNS) disease. f. Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens. g. Prior allogeneic cell transplant. h. Allergy to bovine proteins or to aminoglyoside antibiotics (e.g. gentamicin) or to any product, which may interfere with the treatment. i. Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of StemEx transplantation on overall 100-day mortality.;Secondary Objective: ? Time from infusion of CB cells to overall mortality at 100 days. ? Proportion of overall mortality at 180 days. ? Time from infusion of CB cells to overall mortality at 180 days. ? Proportion of subjects who developed acute Graft versus Host Disease (GvHD) grades III-IV. ? Proportion of subjects with graft failure;Primary end point(s): Overall 100 day mortality | — |
Countries
Hungary, Italy, Spain
Outcome results
None listed