Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

NCT05262465 | Unknown DMC

• 1 other identifier: MST-EAML2020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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;

  2month

Secondary Outcomes (2)

• Disease Free Survival

  2 year

• Overall Survival

  2 year

Other Outcomes (1)

• treatment-related mortality

  2 year

Study Arms (1)

MST for unfit

EXPERIMENTAL

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.

Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion; Drug: Azacitidine; Drug: Venetoclax

Interventions

microtransplantation, HLA-mismatched donor peripheral stem cell infusion BIOLOGICAL

HLA-mismatched donor peripheral stem cell infusion

Also known as: DSI

MST for unfit

Azacitidine DRUG

azacytidine 50-75mg/m2

Also known as: Demethylated drugs

MST for unfit

Venetoclax DRUG

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

Also known as: BCL/2 inhibitor

MST for unfit

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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
• 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.

Sponsors & Collaborators

• guomei: lead

Study Sites (1)

The fifth medical center of PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

yajing huang

CONTACT

+8615811031508; yajing_huang@163.com

mei guo

CONTACT

+8615811031508; 15811031508@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: July 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)