HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines.

• Patients WITH intermediate-risk AML-CR1

• 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

• 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.