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

Primary Purpose

Acute Myeloid Leukemia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

microtransplantation

HLA-mismatched donor peripheral stem cell infusion

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, microtransplantation, elderly patients, HLA-mismatched, donor, Peripheral, stem cell, infusion

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Affiliated Hospital of Academy of Military Medical Sciences ,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CT-group

MST-group

Arm Description

standard induction and consolidation chemotherapy only, without microtransplantation

standard induction and consolidation chemotherapy with microtransplantation

Outcomes

Primary Outcome Measures

the remission rate

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

Disease Free Survival

Measured from complete remission to the date of death or the date of last follow-up examination;

Overall Survival

measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;

Full Information

NCT ID

NCT02171117

First Posted

June 17, 2014

Last Updated

July 12, 2016

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02171117

Brief Title

Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia

Acronym

IMCG-EAML

Official Title

Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

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

Yes

5. Study Description

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.

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, microtransplantation, elderly patients, HLA-mismatched, donor, Peripheral, stem cell, infusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT-group

Arm Type

No Intervention

Arm Description

standard induction and consolidation chemotherapy only, without microtransplantation

Arm Title

MST-group

Arm Type

Experimental

Arm Description

standard induction and consolidation chemotherapy with microtransplantation

Intervention Type

Procedure

Intervention Name(s)

microtransplantation

Other Intervention Name(s)

DSI

Intervention Description

infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)

Intervention Type

Biological

Intervention Name(s)

HLA-mismatched donor peripheral stem cell infusion

Primary Outcome Measure Information:

Title

the remission rate

Description

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Disease Free Survival

Description

Measured from complete remission to the date of death or the date of last follow-up examination;

Time Frame

2 years

Title

Overall Survival

Description

measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;

Time Frame

2 YEAR

Other Pre-specified Outcome Measures:

Title

treatment-related mortality

Description

Early mortality: death within 4 weeks after initiation of induction therapy

Time Frame

2 years

Title

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

Title

donor versus leukemia effect

Description

Analysis of donor WT1 positive CD8 T cells by flow cytometry

Time Frame

2 years

Title

recipient versus leukemia effect

Description

Analysis of recipient WT1 positive CD8 T cells by flow cytometry

Time Frame

2 YEAR

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AI HUISHENG, MD

Phone

86-1066947126

HUISHENGAI@163.COM

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AI HUISEHNG, MD

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

AI HUISHENG, MD

Phone

86-1066947126

HUISEHNGAI@163.COM

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia

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