Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- hematopoietic stem cell microtransplantation-long-term
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- CR rate
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University
Eligibility Criteria
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)
Arms & Interventions
CR group
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.
Intervention: hematopoietic stem cell microtransplantation-long-term
CR group
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.
Intervention: Conditioning for CR group
Non-CR group
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.
Intervention: hematopoietic stem cell microtransplantation-short-term
Non-CR group
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.
Intervention: Conditioning for Non-CR group
Outcomes
Primary Outcomes
CR rate
Time Frame: 2 years
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
relapse rate
Time Frame: 2 years
Secondary Outcomes
- Overall Survival(2 years)
- Disease-free Survival(2 years)
- Incidence of chimerism(2 years)