MTSA: Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03439371

Collaborator

Institut de Cancérologie de la Loire (Other)

Enrollment

Locations

Arm

64.7

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Other: HLA-mismatched micro-transplantation after induction chemotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 8, 2019

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HLA-mismatched micro-transplantation HLA-mismatched micro-transplantation	Other: HLA-mismatched micro-transplantation after induction chemotherapy HLA-mismatched micro-transplantation after induction chemotherapy

Arm

Intervention/Treatment

Experimental: HLA-mismatched micro-transplantation

HLA-mismatched micro-transplantation

Other: HLA-mismatched micro-transplantation after induction chemotherapy

HLA-mismatched micro-transplantation after induction chemotherapy

Outcome Measures

Primary Outcome Measures

Rate of overall survival [2 years]
Rate of overall survival will be reported.

Secondary Outcome Measures

Hematopoietic recovery [3 months]
Number of platelets will be reported.
Hematopoietic recovery [3 months]
Number of neutrophils will be reported.
Hematopoietic recovery [3 months]
Percentage of leukaemic blasts will be reported.
Rate of complete remission [2 years]
Rate of complete remission :
GVHD (graft versus host disease) [2 years]
Presence of graft versus host disease will be reported.
Median overall survival [2 years]
Median overall survival will be calculated.
Median progression-free survival [2 years]
Median progression-free survival will be calculated.
Microchimerism [3 months]
Presence of microchimerism will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Estaing	Clermont-Ferrand	France	63000
2	Centre Hospitalier Universitaire de Grenoble	Grenoble	France
3	CHRU de Lille	Lille	France
4	Centre Hospitalier Lyon Sud	Lyon	France
5	Centre Hospitalier Universitaire de Nancy	Nancy	France
6	Hôpital de la Pitié-Salpêtrière	Paris	France
7	CHU de Saint-Etienne	Saint-Étienne	France	42055