Hematopoietic Stem Cell Microtransplantation for in AML

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: hematopoietic stem cell microtransplantation-short-term; Procedure: hematopoietic stem cell microtransplantation-long-term; Drug: Conditioning for CR group; Drug: Conditioning for Non-CR group

• Registration Number: NCT02676856
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study First Submitted: 2016-01-31
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-08
• Primary Completion: 2018-02
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-CR group	hematopoietic stem cell microtransplantation-short-term	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.
CR group	Conditioning for 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.
CR group	hematopoietic stem cell microtransplantation-long-term	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.
Non-CR group	Conditioning for 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.

Primary Outcome Measures

Name	Time	Method
CR rate	2 years	The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
relapse rate	2 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years
Disease-free Survival	2 years
Incidence of chimerism	2 years	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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China