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Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia (IMCG-EAML)

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ClinicalTrials.gov Identifier: NCT02171117
Recruitment Status : Unknown
Verified July 2016 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 24, 2014
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Tracking Information
First Submitted Date  ICMJE June 17, 2014
First Posted Date  ICMJE June 24, 2014
Last Update Posted Date July 13, 2016
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
the remission rate [ Time Frame: 2 months ]
①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L,platelets of >100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02171117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
  • Disease Free Survival [ Time Frame: 2 years ]
    Measured from complete remission to the date of death or the date of last follow-up examination;
  • Overall Survival [ Time Frame: 2 YEAR ]
    measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2014)
  • treatment-related mortality [ Time Frame: 2 years ]
    Early mortality: death within 4 weeks after initiation of induction therapy
  • donor chimerism or microchimerism [ Time Frame: at count recovery prior to each new cycle of therapy, at 4 weeks after the last round of consolidation, and if still positive, every 3 months after completing therapy for up to 2 years ]
  • donor versus leukemia effect [ Time Frame: 2 years ]
    Analysis of donor WT1 positive CD8 T cells by flow cytometry
  • recipient versus leukemia effect [ Time Frame: 2 YEAR ]
    Analysis of recipient WT1 positive CD8 T cells by flow cytometry
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Official Title  ICMJE Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Brief Summary Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation (MST-group)or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
Detailed Description Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia. Based on these facts, to further validate the therapeutic efficacy, we propose a phase III clinical trial in which the de novo AML patients ≥60 years old are randomly assigned to receive standard induction and consolidation chemotherapy with or without microtransplantation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Procedure: microtransplantation
    infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
    Other Name: DSI
  • Biological: HLA-mismatched donor peripheral stem cell infusion
Study Arms  ICMJE
  • No Intervention: CT-group
    standard induction and consolidation chemotherapy only, without microtransplantation
  • Experimental: MST-group
    standard induction and consolidation chemotherapy with microtransplantation
    Interventions:
    • Procedure: microtransplantation
    • Biological: HLA-mismatched donor peripheral stem cell infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2014)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
  • Patients have not been treated before.
  • 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
  • occurred stroke or intracranial hemorrhage within 6 months before randomization.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02171117
Other Study ID Numbers  ICMJE IMCG-EAML2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study Sponsor  ICMJE The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AI HUISEHNG, MD Affiliated Hospital of Academy of Military Medical Sciences
PRS Account The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP