Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in acute myeloid leukemia (AML) or refractory multiple relapses after chemotherapy. However, all patients with an indication of allo-HSC can not benefit because of two limitations: the toxicity of the treatment and graft shortage available.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

Criteria

Inclusion Criteria:

• Patients with a confirmed diagnosis of acute myeloid leukemia after primary induction treatment failure (persistent leukemia after 2 cycles of induction chemotherapy)

• Patient age ≥ 18 to <60 years

• Cardiac ejection fraction of the left ventricle ≥ 45%

• Lung function - free diffusion capacity for carbon monoxide ≥ 50% of predicted value

• Creatinine clearance ≥ 50 ml / min depending on the CKD-EPI formula

• Availability of an HLA haploidentical donor in the family

• Collection of non-opposition

Exclusion Criteria:

• Uncontrolled invasion of CNS

• Availability of an HLA identical family donor who agreed to donate hematopoietic stem cells OR non-related donor HLA-compatible 10/10 on HLA-A alleles, B, C, and DRB1 DQB1 available and ready to give in 4 weeks to make a decision allograft

• Presence in the patient HLA-specific antibodies directed against an antigen HLA haploidentical donor family

• Karnofsky score <70%

• Patient HIV positive

• Hepatitis B or C or chronic active

• Uncontrolled infection at the time of start packing

• Contraindication to the use of treatments provided by the Protocol

• Previous history of allo-HSC

• No beneficiary of a social security scheme.