Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— MTSA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03439371
• Other study ID #: 2017-1201
• Secondary ID: 2017-A03572-51
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jérôme Cornillon, MD
• Phone: 04 77 91 67 26
• Email: jerome.cornillon[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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 CEBPa 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• HLA-mismatched micro-transplantation after induction chemotherapy
HLA-mismatched micro-transplantation after induction chemotherapy

Locations

Country	Name	City	State
France	CHU Estaing	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Grenoble	Grenoble
France	CHRU de Lille	Lille
France	Centre Hospitalier Lyon Sud	Lyon
France	Centre Hospitalier Universitaire de Nancy	Nancy
France	Hôpital de la Pitié-Salpêtrière	Paris
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of overall survival	Rate of overall survival will be reported.	2 years
Secondary	Hematopoietic recovery	Number of platelets will be reported.	3 months
Secondary	Hematopoietic recovery	Number of neutrophils will be reported.	3 months
Secondary	Hematopoietic recovery	Percentage of leukaemic blasts will be reported.	3 months
Secondary	Rate of complete remission	Rate of complete remission :	2 years
Secondary	GVHD (graft versus host disease)	Presence of graft versus host disease will be reported.	2 years
Secondary	Median overall survival	Median overall survival will be calculated.	2 years
Secondary	Median progression-free survival	Median progression-free survival will be calculated.	2 years
Secondary	Microchimerism	Presence of microchimerism will be reported.	3 months