High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

Detailed Description
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The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells. no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.

Official Title
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Treatment of Relapsed/Refractory Acute Myeloblastic Leukemia(AML) by Infusion of Donor High Dose Allogeneic Mismatched Hematopoietic Stem Cells After Chemotherapy

Conditions
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Leukemia, Myeloid

Intervention / Treatment
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* Biological: hematopoietic stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with relapsed and/or refractory AML Estimated life expectancy ≥ 12 weeks (according to investigator's judgment) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: Previous treatment with investigational gene or cell therapy medicine products Any uncontrolled active medical disorder that would preclude participation as outlined

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hematopoietic stem cell<br>high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy | Biological: hematopoietic stem cell<br>* high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 2 years | 
| Overall survival |  | 2 years | 
| donor graft rate |  | 6 months | 
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell