Clinical trial NCT02171117: Safety and Efficacy Study of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Official title: Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
microtransplantation
elderly patients
HLA-mismatched
donor
Peripheral
stem cell
infusion
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 196
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the remission rate
timeFrame: 2 months
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 YEAR
Other outcomes:
measure: treatment-related mortality
timeFrame: 2 years
measure: donor chimerism or microchimerism
timeFrame: 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
measure: donor versus leukemia effect
timeFrame: 2 years
measure: recipient versus leukemia effect
timeFrame: 2 YEAR
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences ,
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: AI HUISEHNG, MD
role: PRINCIPAL_INVESTIGATOR
References: