This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
HLA-mismatched micro-transplantation after induction chemotherapy
CHU Estaing
Clermont-Ferrand, France
RECRUITINGCentre Hospitalier Universitaire de Grenoble
Grenoble, France
RECRUITINGCHRU de Lille
Lille, France
Rate of overall survival
Rate of overall survival will be reported.
Time frame: 2 years
Hematopoietic recovery
Number of platelets will be reported.
Time frame: 3 months
Hematopoietic recovery
Number of neutrophils will be reported.
Time frame: 3 months
Hematopoietic recovery
Percentage of leukaemic blasts will be reported.
Time frame: 3 months
Rate of complete remission
Rate of complete remission :
Time frame: 2 years
GVHD (graft versus host disease)
Presence of graft versus host disease will be reported.
Time frame: 2 years
Median overall survival
Median overall survival will be calculated.
Time frame: 2 years
Median progression-free survival
Median progression-free survival will be calculated.
Time frame: 2 years
Microchimerism
Presence of microchimerism will be reported.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre Hospitalier Lyon Sud
Lyon, France
RECRUITINGCentre Hospitalier Universitaire de Nancy
Nancy, France
NOT_YET_RECRUITINGHôpital de la Pitié-Salpêtrière
Paris, France
NOT_YET_RECRUITINGCHU de Saint-Etienne
Saint-Etienne, France
RECRUITING