Hematopoietic Stem Cell Microtransplantation for in AML

December 6, 2017 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Drug: Conditioning for CR group
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Experimental: 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.
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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse rate
Time Frame: 2 years
2 years
CR rate
Time Frame: 2 years
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years
2 years
Disease-free Survival
Time Frame: 2 years
2 years
Incidence of chimerism
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 31, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microtransplantation-AML-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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