HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk
Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2004
Longer than P75 for phase_3
1 active site
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
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedJune 4, 2015
May 1, 2015
9 years
May 18, 2015
June 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
10 years
Secondary Outcomes (5)
treatment-related mortality
2 years
donor chimerism or microchimerism
10 years
WT1+CD8+CTL
10 years
GVHD
10 years
disease free survival
10 years
Study Arms (2)
MST（microtransplantation）
EXPERIMENTALThe 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.
NST（nonmyeloablative transplantation）
ACTIVE COMPARATORThe 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
Interventions
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
30 mg/m2/d for 5days
1.5-2 mg/kg/d for 4 days
40 mg/kg/d for 2 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ai huisheng
Affiliated Hospital of Academy of Military Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
June 3, 2015
Study Start
May 1, 2004
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 4, 2015
Record last verified: 2015-05