high risk acute leukemia MedDRA version: 9.1 Level: LLT Classification code 10060930 Term: Acute leukaemia in remission
Conditions
Interventions
Product Name: T donor lymphocytes genetically modified with the retroviral vector SFCMM-3 Mut2 #48.
Pharmaceutical Form: Solution for infusion
Other descriptive name: SFCMM-3 Mut2 #48 transduced lymph
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age ≥ 18 years Any of the following conditions: - AML and ALL in 1st complete remission (CR) at high risk of relapse based on negative prognostic factors - AML and ALL in 2nd or subsequent CR - secondary AML in CR Absence of HLA matched family or unrelated donor Stable clinical conditions and life expectancy 3 months PS ECOG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with life-threatening condition or complication other than their basic disease. Contraindication to haploidentical HCT as defined by the Investigator Patients with active CNS disease Pregnant or lactating women Exclusion criteria for HSV-Tk infusion: Infections requiring administration of ganciclovir or acyclovir at the time of infusion GvHD requiring systemic immunosuppressive therapy Ongoing systemic immunosuppressive therapy after haploidentical HCT Administration of G-CSF after haploidentical HCT CD3+ cells ≥100 /µl at day of planned experimental infusion after haploidentical HCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the cumulative incidence of extensive chronic GvHD (cGvHD) in high risk leukemia patients who underwent haploidentical HCT followed by add back strategy of HSV-Tk donor lymphocytes or haploidentical HCT followed by any T cell repletion strategy. 2. To compare the overall survival (OS) in the two treatment arms;Secondary Objective: To compare engraftment rate, cumulative incidence of grade II-IV acute GvHD and time to T-cell immune reconstitution in the two treatment arms To compare incidence and duration of infectious episodes and infectious disease mortality in the two treatment arms To compare transplant-related mortality (TRM), cumulative incidence of relapse (CIR), and disease-free survival (DFS) in the two treatment arms To evaluate the acute and long-term toxicity related to the HSV-Tk infusions To assess quality of life (QoL) and Medical Care Utilization (MCU) in both arms;Primary end point(s): 1. To compare the cumulative incidence of extensive chronic GvHD (cGvHD) in high risk leukemia patients who underwent haploidentical HCT followed by add back strategy of HSV-Tk donor lymphocytes or haploidentical HCT followed by any T cell repletion strategy. 2. To compare the overall survival (OS) in the two treatment arms | — |
Countries
Italy
Outcome results
None listed