Hematopoietic Stem Cell Microtransplantation for in AML

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).

Detailed Description
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Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.

Official Title
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Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Procedure: hematopoietic stem cell microtransplantation-long-term
* Procedure: hematopoietic stem cell microtransplantation-short-term
* Drug: Conditioning for CR group
* Drug: Conditioning for Non-CR group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy Intolerance or unwillingness of allogeneic HSCT Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR group<br>For the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course. | Procedure: hematopoietic stem cell microtransplantation-long-term<br>* Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once.<br>Drug: Conditioning for CR group<br>* For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).<br>|
| Experimental: Non-CR group<br>For the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course. | Procedure: hematopoietic stem cell microtransplantation-short-term<br>* Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once.<br>Drug: Conditioning for Non-CR group<br>* For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate | The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation | 2 years | 
| relapse rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2 years | 
| Disease-free Survival |  | 2 years | 
| Incidence of chimerism | Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia, hematopoietic stem cell microtransplantation