NCT02676856

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 8, 2017

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 31, 2016

Last Update Submit

December 6, 2017

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemiahematopoietic stem cell microtransplantation

Outcome Measures

Primary Outcomes (2)

  • CR rate

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

    2 years

  • relapse rate

    2 years

Secondary Outcomes (3)

  • Overall Survival

    2 years

  • Disease-free Survival

    2 years

  • Incidence of chimerism

    2 years

Study Arms (2)

CR group

EXPERIMENTAL

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.

Procedure: hematopoietic stem cell microtransplantation-long-termDrug: Conditioning for CR group

Non-CR group

EXPERIMENTAL

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.

Procedure: hematopoietic stem cell microtransplantation-short-termDrug: Conditioning for Non-CR group

Interventions

hematopoietic stem cell microtransplantation-long-termPROCEDURE

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

CR group
hematopoietic stem cell microtransplantation-short-termPROCEDURE

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

Non-CR group
Conditioning for CR groupDRUG

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

CR group
Conditioning for Non-CR groupDRUG

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).

Non-CR group

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

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

    PMID: 26137066BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fen Huang

CONTACT

+86-020-6278788313826204917@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

December 8, 2017

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)