Hematopoietic Stem Cell Microtransplantation for in AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676856
• Other study ID #: Microtransplantation-AML-2016
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2016
• Last updated: December 6, 2017
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2016
• Source: Nanfang Hospital of Southern Medical University
• Contact: Fen Huang
• Phone: +86-020-62787883
• Email: 13826204917[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.
• 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).
• 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).

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Guangzhou First People's Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. Epub 2015 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR rate	The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation	2 years
Primary	relapse rate		2 years
Secondary	Overall Survival		2 years
Secondary	Disease-free Survival		2 years
Secondary	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