Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLA-mismatched micro-transplantation after induction chemotherapy.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: 60 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)
Overview
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.
Detailed description
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.
Interventions
- Other HLA-mismatched micro-transplantation after induction chemotherapy
HLA-mismatched micro-transplantation after induction chemotherapy
Primary outcome measures
- Rate of overall survival [Time frame: 2 years]
Secondary outcome measures (8)
- Hematopoietic recovery [Time frame: 3 months]
- Hematopoietic recovery [Time frame: 3 months]
- Hematopoietic recovery [Time frame: 3 months]
- Rate of complete remission [Time frame: 2 years]
- GVHD (graft versus host disease) [Time frame: 2 years]
- Median overall survival [Time frame: 2 years]
- Median progression-free survival [Time frame: 2 years]
- Microchimerism [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (<5% blasts)
- Contra-indication to conditioning regimen in conventional allogeneic transplantation
Exclusion criteria
- Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
- Promyelocytic leukemia t(15;17)
- CBF-AML t(8;21) or inv(16)
- Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refusing participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 7 centers
- CHU Estaing — Clermont-Ferrand
- Centre Hospitalier Universitaire de Grenoble — Grenoble
- CHRU de Lille — Lille
- Centre Hospitalier Lyon Sud — Lyon
- Centre Hospitalier Universitaire de Nancy — Nancy
- Hôpital de la Pitié-Salpêtrière — Paris
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT03439371 · 2017-1201 · 2017-A03572-51