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Early Tapering of Immunosuppressive Agents to Immunomodulation to Improve Survival of AML Patients

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ClinicalTrials.gov Identifier: NCT03150134
Recruitment Status : Unknown
Verified May 2017 by Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

Early reduction of immunosuppressive agents after HLA matched donor transplantation can improve the survival of advanced stage acute myeloid leukemia.

single-center, open clinical study


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Disorder Related to Bone Marrow Transplantation Drug: Cyclosporine Drug: routine reduction of immunosuppressive drugs(cyclosporine) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Tapering of Immunosuppressive Agents After Allogeneic Hematopoietic Stem Cell Transplantation Can Improve the Survival of Patients With Advanced Acute Myeloid Leukemia.
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
Experimental: early reduction
Usually in the absence of GvHD, immunosuppressive drugs(Cyclosporine) were gradually reduced by 6 weeks and discontinued in three months after transplant in the advanced patients while immunosuppressive agents were gradually reduced by 2 months and discontinued in four months after transplant in the advanced patients in haploidentical SCT even if complete donor chimerism (CDC) achieved. If donor chimerism had not achieved CDC with no significant acute GVHD at four weeks after HSCT, immunosuppressive agents were gradually reduced. If GvHD was present during the time of immunosuppressive agents reduction, CsA was added again and tapering was done over longer periods.
Drug: Cyclosporine
Patients with advanced AML received early tapering of immunosuppressive drugs(Cyclosporine)
Other Name: immunosuppressive agents

Placebo Comparator: routine reduction
Arm/Group Descriptions.Immunosuppressive drugs(cyclosporine) were routine reduced by 3 months and discontinued in the 5 months without GvHD in the CR group. We used the result of chimerism as the reference.
Drug: routine reduction of immunosuppressive drugs(cyclosporine)
patients with AML in CR were given the routine reduction of immunosuppressive drugs(cyclosporine)
Other Name: cyclosporine




Primary Outcome Measures :
  1. relapse free survival(RFS) [ Time Frame: 2 years ]
    PFS were defined as the time from stem-cell infusion to relapse, disease progression from any cause.


Secondary Outcome Measures :
  1. Progress free survival (PFS) rate [ Time Frame: 2 years ]
    PFS were defined as the time from stem-cell infusion to relapse, disease progression,or death from any cause

  2. Overall survival rate [ Time Frame: 2 years ]
    OS were defined as the time from stem-cell infusion to death from any cause

  3. Transplant related mortality [ Time Frame: up to 2 year ]
    TRM were defined as death within 100 days of high-dose therapy not related to the disease,relapse or progression



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - According to the World Health Organization (WHO) classification,patients diagnosed with acute myeloid leukemia were enrolled in this study.

Performance status scores no more than 2 (ECOG criteria). Adequate organ function as defined by the following criteria: alanine transaminase (ALT), aspartate transaminase(AST) and total serum bilirubin <2×ULN (upper limit of normal) Serum creatinine and blood urea nitrogen(BUN) <1.25×ULN. Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation(the patients has been improved after treatment of the disease and are not expected to affect transplant can include in the study).

Absence of any other contraindications of stem cell transplantation. Willingness and ability to perform HSCT. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Presence of any condition inappropriate for HSCT. Life expectancy < 3 months because of other severe diseases. Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure et al.

Uncontrolled infection. Pregnancy or breastfeeding. Has enrolled in anther clinical trials Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.


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): NCT03150134


Contacts
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Contact: jun yang yang, master 18001890183 yangjuan74@hotmail.com
Contact: xianminsong song, doctor 13501672508 shongxm@139.com

Locations
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China, Shanghai
Shanghai First People's HOSPITAL Recruiting
Shanghai, Shanghai, China, 200127
Contact: YANG JUN, master    13564880726    yangjuan74@hotmail.com   
Contact: song xianmin, doctor    13501672508    shongxm@sjtu.edu.cn   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: xinpeng wang, doctor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yang Jun, Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03150134    
Other Study ID Numbers: 2017KY21
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yang Jun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Acute Myeloid Leukemia
transplantation
allogeneic transplantation
immunosuppressive agents
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclosporine
Cyclosporins
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors