HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

June 2, 2015 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Affiliated Hospital of Academy of Military Medical Sciences ,

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

9 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines.
  • Patients WITH intermediate-risk AML-CR1
  • Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
  • Patients must have a HLA mismatched donor who should be able to provide informed consent.
  • All genders and races are eligible.
  • ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
  • By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
  • Donors must be able to safely undergo leukapheresis.

Exclusion Criteria:

  • received operation 4 weeks before randomization
  • acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
  • active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
  • Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
  • There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
  • Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
  • Any situation processed by the PI that will be damaged to the patients safety.
  • Patients and / or authorized family member refuse to sign the consent. attend other clinical researchers in 3 months.
  • Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MST（microtransplantation）
The microtransplantation conditioning regimen included high-dose Ara-C chemotherapy (2.0 to 2.5 g/m2 per 12 hours intravenously on days -4 to -2) followed by an infusion of HLA mismatched stem cell 24 hours (day 0) after the completion of cytarabine.
Genetic: HLA mismatched stem cell
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
Other Names:
  • microtransplantation
Drug: Ara-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
Other Names:
  • conditioning reginmen
Active Comparator: NST（nonmyeloablative transplantation）
The NST（nonmyeloablative transplantation）conditioning regimen consisted of 30 mg/m2/d fludarabine for days -6 to -2, 1.5-2 mg/kg/d anti-lymphocyte globulin for days -5 to -2, 40 mg/kg/d cyclophosphamide for days -4 and -2 and 2.0-3.0 g/m2/d cytarabine for days -6 to -4，followed by an infusion of HLA matched stem cell after the completion of regimen. The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Drug: Ara-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
Other Names:
  • conditioning reginmen
Genetic: HLA matched stem cell
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
Other Names:
  • nonmyeloablative transplantation
Drug: cyclosporine A
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Other Names:
  • GVHD prophylaxis
Drug: Mycophenolate mofetil
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Other Names:
  • GVHD prophylaxis
Drug: fludarabine
30 mg/m2/d for 5days
Other Names:
  • NST conditioning reginmen
Drug: anti-lymphocyte globulin
1.5-2 mg/kg/d for 4 days
Other Names:
  • NST conditioning reginmen
Drug: cyclophosphamide
40 mg/kg/d for 2 days
Other Names:
  • NST conditioning reginmen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 10 years
10 years
treatment-related mortality
Time Frame: 2 years
2 years
donor chimerism or microchimerism
Time Frame: 10 years
10 years
WT1+CD8+CTL
Time Frame: 10 years
donor versus leukemia effect
10 years
GVHD
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

  • Principal Investigator: ai huisheng, Affiliated Hospital of Academy of Military Medical Sciences

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

May 1, 2004

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 31, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST vs NST

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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