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Hematopoietic Stem Cell Microtransplantation for in AML

Primary Purpose

Acute Myeloid Leukemia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

hematopoietic stem cell microtransplantation-long-term

hematopoietic stem cell microtransplantation-short-term

Conditioning for CR group

Conditioning for Non-CR group

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, hematopoietic stem cell microtransplantation

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CR group

Non-CR group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

CR rate

The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation

relapse rate

Secondary Outcome Measures

Overall Survival

Disease-free Survival

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.

Full Information

NCT ID

NCT02676856

First Posted

January 31, 2016

Last Updated

December 6, 2017

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02676856

Brief Title

Hematopoietic Stem Cell Microtransplantation for in AML

Official Title

Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (Actual)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia, hematopoietic stem cell microtransplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CR group

Arm Type

Experimental

Arm Description

Arm Title

Non-CR group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

hematopoietic stem cell microtransplantation-long-term

Intervention Description

Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once.

Intervention Type

Procedure

Intervention Name(s)

hematopoietic stem cell microtransplantation-short-term

Intervention Description

Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once.

Intervention Type

Drug

Intervention Name(s)

Conditioning for CR group

Intervention Description

For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).

Intervention Type

Drug

Intervention Name(s)

Conditioning for Non-CR group

Intervention Description

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).

Primary Outcome Measure Information:

Title

CR rate

Description

The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation

Time Frame

2 years

Title

relapse rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

2 years

Title

Disease-free Survival

Time Frame

2 years

Title

Incidence of chimerism

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fen Huang

Phone

+86-020-62787883

13826204917@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qifa Liu

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanfang Hospital, Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fen Huang

Phone

+86-020-62787883

13826204917@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26137066

Citation

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. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27.

Results Reference

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Hematopoietic Stem Cell Microtransplantation for in AML

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