Hematological malignancies confirmed histologically and not rapidly progressing: - AML in Complete Remission
Conditions
Interventions
Product Name: mesenchymal stem cells
Product Code: MSC
Pharmaceutical Form:
Current Sponsor code: MSC
Concentration type: equal
Concentration number: 1.5 x 10E6MSC/kg--3.0 x 10E6MSC/kg
Pharmaceutic
Sponsors
CHU de Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient 1. Hematological malignancies confirmed histologically and not rapidly progressing (see E1.1). 2. Theoretical indication for a standard allo-transplant, but not feasible because: Age > 55 yrs. Unacceptable end organ performance. Patient’s refusal. 3. Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant. 4. Male or female; fertile female patients must use a reliable contraception method; 5. Age 15 Kg (because of leukapheresis); 4. Fulfills generally accepted criteria for allogeneic PBSC donation; 5. Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures. MSC donors 1. Related to the recipient (sibling, parent or child) or unrelated; 2. Male or female; 3. Age > 16 yrs (no age limit if same as HSC donor); 4. No HLA matching required; 5. Fulfills generally accepted criteria for allogeneic HSC donation; 6. Informed consent given by donor or his/her guardian if of minor age. Are the trial subjects under 18? yes 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient 1. Any condition not fulfilling inclusion criteria; 2. HIV positive; 3. Terminal organ failure, except for renal failure (dialysis acceptable) - Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction 3 mg/dL, and symptomatic biliary disease; 4- Uncontrolled infection, arrhythmia or hypertension; 5- Previous radiation therapy precluding the use of 2 Gy TBI; 6- 10/10 HLA-A, -B, -C, DRB1 and DQBI allele-matched donor fit to/willing to donate PBSC. PBSC donor 1. Any condition not fulfilling inclusion criteria; 2. HIV positive; 3. Unable to undergo leukapheresis because of poor vein access or other reasons. MSC donor 1. Any condition not fulfilling inclusion criteria; 2. HIV positive; 3. Known allergy to lidocaine; 4. If donor other than HSC donor: any risk factor for transmissible infectious diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present project aims at evaluating the capacity of mesenchymal stem cells to improve one-year overall survival of patients transplanted with HLA-mismatched peripheral blood stem cells from related or unrelated donors after non-myeloablative conditioning. ;Secondary Objective: Not applicable;Primary end point(s): To compare one-year overall survival between patients treated with MSC or placebo.;Timepoint(s) of evaluation of this end point: One year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate in each arm: 1.the incidences of grade II-IV and grade III-IV acute GVDH disease. 2.the cumulative incidence of nonrelapse mortality at days 100, 365 and 730. 3.the incidence of extensive chronic GVHD (at day 365). 4.the incidence of graft rejection.5.the cumulative incidence of relapse at days 365 and 730. 6.the incidence of progression-free survival (at days 365 and 730). 7.the incidence of infections (at day 100). 8.To investigate the quality and timing of immunologic reconstitution in each arm. 9.To detect MSC of MSC donor origin in recipient marrow after hematopoietic cell transplantation (HCT) in patients given MSC (ULg-CHU patients only). 10.To assess the proportion of patients with measurable disease at HCT who achieve a complete response in each arm. 11.To compare the number of absolute donor T cells on day 28 after in each arm. 12.To compare these endpoints in patients conditioned with either fludarabine and 2 Gy TBI or fludarabine-busulfan-ATG.;Timepoint(s) of evaluation of this end point: 1.grade II-IV and grade III-IV acute GVDH disease the first three months. 2.nonrelapse mortality at days 100, 365 and 730. 3.chronic GVHD at day 365. 4.the incidence of graft rejection at days 28, 40, 60, 80, 100, 120, 180, 365 and 730 . 5.relapse at days 365 and 730. 6.PFS at days 365 and 730. 7.infections at day 100. 8.immunologic reconstitution at days 28, 40, 60, 80, 100, 120, 180, 365 and 730. 9.to detect MSC of MSC donor origin at days 40 and 100. 10.complete response in each arm at day 730. 11.To compare the number of absolute donor T cells on day 28 after in each arm. 12.To compare these endpoints in patients conditioned with either fludarabine and 2 Gy TBI or fludarabine-busulfan-ATG. | — |
Countries
Belgium
Contacts
Public ContactYves Beguin
CHU de Liège
Outcome results
None listed