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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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
- Overall survival rate [ Time Frame: 2 years ]OS were defined as the time from stem-cell infusion to death from any cause
- 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
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
|Contact: jun yang yang, email@example.com|
|Contact: xianminsong song, firstname.lastname@example.org|
|Study Chair:||xinpeng wang, doctor||Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|