NCT02676856

Hematopoietic Stem Cell Microtransplantation for in AML

Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	hematopoietic stem cell microtransplantation-long-term	Stem cell infusion are administrated once three months for 3 times with the cell count of 3\*10\^8/kg/once.
PROCEDURE	hematopoietic stem cell microtransplantation-short-term	Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3\*10\^8/kg/once.
DRUG	Conditioning for CR group	For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
DRUG	Conditioning for Non-CR group	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).

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2016-02-08
• Last updated: 2017-12-08

Locations

1 site across 1 country: China