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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

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: microtransplantation Biological: HLA-mismatched donor peripheral stem cell infusion Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Study Start Date : March 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
No Intervention: CT-group
standard induction and consolidation chemotherapy only, without microtransplantation
Experimental: MST-group
standard induction and consolidation chemotherapy with microtransplantation
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



Primary Outcome Measures :
  1. 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;


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 2 years ]
    Measured from complete remission to the date of death or the date of last follow-up examination;

  2. 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;


Other Outcome Measures:
  1. treatment-related mortality [ Time Frame: 2 years ]
    Early mortality: death within 4 weeks after initiation of induction therapy

  2. 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 ]
  3. donor versus leukemia effect [ Time Frame: 2 years ]
    Analysis of donor WT1 positive CD8 T cells by flow cytometry

  4. recipient versus leukemia effect [ Time Frame: 2 YEAR ]
    Analysis of recipient WT1 positive CD8 T cells by flow cytometry



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171117


Contacts
Contact: AI HUISHENG, MD 86-1066947126 HUISHENGAI@163.COM

Locations
China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences , Recruiting
Beijing, Beijing, China, 100071
Contact: AI HUISHENG, MD    86-1066947126    HUISEHNGAI@163.COM   
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
Principal Investigator: AI HUISEHNG, MD Affiliated Hospital of Academy of Military Medical Sciences

Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02171117     History of Changes
Other Study ID Numbers: IMCG-EAML2014
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Acute Myeloid Leukemia
microtransplantation
elderly patients
HLA-mismatched
donor
Peripheral
stem cell
infusion

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms