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

NCT02171117 | Unknown Phase 3 DMC

• 1 other identifier: IMCG-EAML2014
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; microtransplantation; elderly patients; HLA-mismatched; donor; Peripheral; stem cell; infusion

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;

  2 months

Secondary Outcomes (2)

• Disease Free Survival

  2 years

• Overall Survival

  2 YEAR

Other Outcomes (4)

• treatment-related mortality

  2 years

• 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

• donor versus leukemia effect

  2 years

Study Arms (2)

CT-group

NO INTERVENTION

standard induction and consolidation chemotherapy only, without microtransplantation

MST-group

EXPERIMENTAL

standard induction and consolidation chemotherapy with microtransplantation

Procedure: microtransplantation; Biological: HLA-mismatched donor peripheral stem cell infusion

Interventions

microtransplantation PROCEDURE

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

Also known as: DSI

MST-group

HLA-mismatched donor peripheral stem cell infusion BIOLOGICAL

MST-group

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

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead

Study Sites (1)

Affiliated Hospital of Academy of Military Medical Sciences ,

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• AI HUISEHNG, MD

  Affiliated Hospital of Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AI HUISHENG, MD

CONTACT

86-1066947126; HUISHENGAI@163.COM

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 24, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

CN (1)