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

Acute Myeloid Leukemia Clinical Trial

— IMCG-EAML  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02171117
• Other study ID #: IMCG-EAML2014
• Status: Recruiting
• Phase: Phase 3
• First received: June 17, 2014
• Last updated: July 12, 2016
• Start date: March 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2016
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: AI HUISHENG, MD
• Phone: 86-1066947126
• Email: HUISHENGAI[@]163.COM
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Biological:
• HLA-mismatched donor peripheral stem cell infusion

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences ,	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	treatment-related mortality	Early mortality: death within 4 weeks after initiation of induction therapy	2 years	Yes
Other	donor chimerism or microchimerism		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	No
Other	donor versus leukemia effect	Analysis of donor WT1 positive CD8 T cells by flow cytometry	2 years	No
Other	recipient versus leukemia effect	Analysis of recipient WT1 positive CD8 T cells by flow cytometry	2 YEAR	No
Primary	the remission rate	?bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).?Hemogram: absolute neutrophil count of more than 1.0×109/L,platelets of >100×109/L. ?Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;	2 months	No
Secondary	Disease Free Survival	Measured from complete remission to the date of death or the date of last follow-up examination;	2 years	No
Secondary	Overall Survival	measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;	2 YEAR	No