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Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

Primary Purpose

Adult Acute Myeloid Leukemia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

microtransplantation, HLA-mismatched donor peripheral stem cell infusion

Azacitidine

Venetoclax

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia

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

The fifth medical center of PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MST for unfit

Arm Description

Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy. Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses.

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

NCT05262465

First Posted

February 21, 2022

Last Updated

February 21, 2022

Sponsor

guomei

1. Study Identification

Unique Protocol Identification Number

NCT05262465

Brief Title

Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

Official Title

A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

guomei

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.

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. In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect. Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MST for unfit

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

microtransplantation, HLA-mismatched donor peripheral stem cell infusion

Other Intervention Name(s)

DSI

Intervention Description

HLA-mismatched donor peripheral stem cell infusion

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Other Intervention Name(s)

Demethylated drugs

Intervention Description

azacytidine 50-75mg/m2

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Other Intervention Name(s)

BCL/2 inhibitor

Intervention Description

Venetoclax 100-300mg/d ×3d，400mg 4-28d

Primary Outcome Measure Information:

Title

the remission rate

Description

Time Frame

2month

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 year

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 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

yajing huang

Phone

+8615811031508

yajing_huang@163.com

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

mei guo

Phone

+8615811031508

15811031508@163.com

Facility Information:

Facility Name

The fifth medical center of PLA General Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mei guo

Phone

+8615811031508

15811031508@163.com

First Name & Middle Initial & Last Name & Degree

yajing huang

Phone

+8615811031508

yajing_huang@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

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