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

Acute Myeloid Leukemia Clinical Trial

Official title:

Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461121
• Other study ID #: MST vs NST
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2015
• Last updated: June 2, 2015
• Start date: May 2004
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Description:

The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Genetic:
• HLA mismatched stem cell
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
• HLA matched stem cell
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen

Drug:
• cyclosporine A
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
• Mycophenolate mofetil
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
• Ara-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
• fludarabine
30 mg/m2/d for 5days
• anti-lymphocyte globulin
1.5-2 mg/kg/d for 4 days
• cyclophosphamide
40 mg/kg/d for 2 days

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
Primary	Overall Survival		10 years	No
Secondary	treatment-related mortality		2 years	Yes
Secondary	donor chimerism or microchimerism		10 years	No
Secondary	WT1+CD8+CTL	donor versus leukemia effect	10 years	No
Secondary	GVHD		10 years	Yes
Secondary	disease free survival		10 years	No