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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HLA mismatched stem cell
HLA matched stem cell
cyclosporine A
Mycophenolate mofetil
Ara-C
fludarabine
anti-lymphocyte globulin
cyclophosphamide
Sponsored by
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, microtransplantationHLA-mismatched microtransplantation, nonmyeloablative stem cell transplantation, graft-versus-host disease

Eligibility Criteria

9 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Hospital of Academy of Military Medical Sciences ,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MST（microtransplantation）

NST（nonmyeloablative transplantation）

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

treatment-related mortality
donor chimerism or microchimerism
WT1+CD8+CTL
donor versus leukemia effect
GVHD
disease free survival

Full Information

First Posted
May 18, 2015
Last Updated
June 2, 2015
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02461121
Brief Title
HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk
Official Title
Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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, microtransplantationHLA-mismatched microtransplantation, nonmyeloablative stem cell transplantation, graft-versus-host disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MST（microtransplantation）
Arm Type
Experimental
Arm Description
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.
Arm Title
NST（nonmyeloablative transplantation）
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Genetic
Intervention Name(s)
HLA mismatched stem cell
Other Intervention Name(s)
microtransplantation
Intervention Description
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
Intervention Type
Genetic
Intervention Name(s)
HLA matched stem cell
Other Intervention Name(s)
nonmyeloablative transplantation
Intervention Description
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
Intervention Type
Drug
Intervention Name(s)
cyclosporine A
Other Intervention Name(s)
GVHD prophylaxis
Intervention Description
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Other Intervention Name(s)
GVHD prophylaxis
Intervention Description
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
Ara-C
Other Intervention Name(s)
conditioning reginmen
Intervention Description
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
Intervention Type
Drug
Intervention Name(s)
fludarabine
Other Intervention Name(s)
NST conditioning reginmen
Intervention Description
30 mg/m2/d for 5days
Intervention Type
Drug
Intervention Name(s)
anti-lymphocyte globulin
Other Intervention Name(s)
NST conditioning reginmen
Intervention Description
1.5-2 mg/kg/d for 4 days
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
NST conditioning reginmen
Intervention Description
40 mg/kg/d for 2 days
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
10 years
Secondary Outcome Measure Information:
Title
treatment-related mortality
Time Frame
2 years
Title
donor chimerism or microchimerism
Time Frame
10 years
Title
WT1+CD8+CTL
Description
donor versus leukemia effect
Time Frame
10 years
Title
GVHD
Time Frame
10 years
Title
disease free survival
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ai huisheng
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences ,
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

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

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