Clinical trial · Interventional
Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia
Sequential Chemotherapy Prior to Reduced Intensity Conditioning: Interventional Study in Haploidentical Hematopoietic Stem Cells Transplantation for Patients With Refractory Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care supports | Drug | — | UNRESOLVED |
| Lymphocyte injection of prophylactic donor (PDLI) | Drug | — | UNRESOLVED |
| Prevention of GVHD | Drug | — | UNRESOLVED |
| Sequential Packaging (SET) | Drug | — | UNRESOLVED |
| Transfusion graft | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with primary refractory acute myeloid leukemia
- description
- Patients with primary refractory acute myeloid leukemia
- interventionNames
- Drug: Sequential Packaging (SET)
- Drug: Transfusion graft
- Drug: Prevention of GVHD
- Drug: Care supports
- Drug: Lymphocyte injection of prophylactic donor (PDLI)
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 2 years after transplantation
- description
- The aim is to describe the efficacy of the combination of a SET followed by haploidentical transplant with post-transplant immune modulation by pDLI in patients with AML. The main objective is to assess overall survival at 2 years in these patients.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available