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

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

NCT ID: NCT02171117

Condition: Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Conditions: Keywords:
Acute Myeloid Leukemia
microtransplantation
elderly patients
HLA-mismatched
donor
Peripheral
stem cell
infusion

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: microtransplantation
Description: infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
Arm group label: MST-group

Other name: DSI

Intervention type: Biological
Intervention name: HLA-mismatched donor peripheral stem cell infusion
Arm group label: MST-group

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.

Criteria for 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.

Gender: All

Minimum age: 60 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Affiliated Hospital of Academy of Military Medical Sciences ,

Address:
City: Beijing
Zip: 100071
Country: China

Status: Recruiting

Contact:
Last name: AI HUISHENG, MD

Phone: 86-1066947126
Email: HUISEHNGAI@163.COM

Start date: March 2014

Completion date: June 2018

Lead sponsor:
Agency: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Agency class: Other

Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02171117