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

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ClinicalTrials.gov Identifier: NCT02461121
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Genetic: HLA mismatched stem cell Genetic: HLA matched stem cell Drug: cyclosporine A Drug: Mycophenolate mofetil Drug: Ara-C Drug: fludarabine Drug: anti-lymphocyte globulin Drug: cyclophosphamide Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk
Study Start Date : May 2004
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


Arm Intervention/treatment
Experimental: MST(microtransplantation)
The microtransplantation conditioning regimen included high-dose Ara-C chemotherapy (2.0 to 2.5 g/m2 per 12 hours intravenously on days -4 to -2) followed by an infusion of HLA mismatched stem cell 24 hours (day 0) after the completion of cytarabine.
Genetic: HLA mismatched stem cell
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
Other Name: microtransplantation

Drug: Ara-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
Other Name: conditioning reginmen

Active Comparator: NST(nonmyeloablative transplantation)
The NST(nonmyeloablative transplantation)conditioning regimen consisted of 30 mg/m2/d fludarabine for days -6 to -2, 1.5-2 mg/kg/d anti-lymphocyte globulin for days -5 to -2, 40 mg/kg/d cyclophosphamide for days -4 and -2 and 2.0-3.0 g/m2/d cytarabine for days -6 to -4,followed by an infusion of HLA matched stem cell after the completion of regimen. The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Genetic: HLA matched stem cell
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
Other Name: nonmyeloablative transplantation

Drug: cyclosporine A
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Other Name: GVHD prophylaxis

Drug: Mycophenolate mofetil
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Other Name: GVHD prophylaxis

Drug: Ara-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
Other Name: conditioning reginmen

Drug: fludarabine
30 mg/m2/d for 5days
Other Name: NST conditioning reginmen

Drug: anti-lymphocyte globulin
1.5-2 mg/kg/d for 4 days
Other Name: NST conditioning reginmen

Drug: cyclophosphamide
40 mg/kg/d for 2 days
Other Name: NST conditioning reginmen




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. treatment-related mortality [ Time Frame: 2 years ]
  2. donor chimerism or microchimerism [ Time Frame: 10 years ]
  3. WT1+CD8+CTL [ Time Frame: 10 years ]
    donor versus leukemia effect

  4. GVHD [ Time Frame: 10 years ]
  5. disease free survival [ Time Frame: 10 years ]


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Ages Eligible for Study:   9 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461121


Locations
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China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences ,
Beijing, Beijing, China, 100071
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Principal Investigator: ai huisheng Affiliated Hospital of Academy of Military Medical Sciences

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02461121     History of Changes
Other Study ID Numbers: MST vs NST
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Acute Myeloid Leukemia
microtransplantationHLA-mismatched microtransplantation
nonmyeloablative stem cell transplantation
graft-versus-host disease
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclosporine
Mycophenolic Acid
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Cyclosporins
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular