Thrombocytopenia Clinical Trial
Official title:
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy
The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by chemotherapy in patients with acute leukemia (AL).
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age:14-65 years - achieve complete remission of acute leukemia - the first course of consolidation chemotherapy - ECOG grades 0 or 1 - expected survival time = three months - Subjects (or their legally acceptable representatives) must have signed an informed consent document. Exclusion Criteria: - cardiac dysfunction (particularly congestive heart failure), hepatic abnormalities (bilirubin = 3 mg/dL, aminotransferase> 2 times the upper limit of normal), renal dysfunction (creatinine clearance rate < 30 mL/min) - Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) - Patients with any conditions not suitable for the trial (investigators' decision) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University | Academy Military Medical Science, China, Guangdong General Hospital, Guangzhou First Municipal People’s Hospital, Guangzhou General Hospital of Guangzhou Military Command, Huazhong University of Science and Technology, Peking University People's Hospital, Southern Medical University, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University |
China,
Xi J, Zhu H, Liu D, Nan X, Zheng W, Liu K, Shi W, Chen L, Lv Y, Yan F, Li Y, Xie X, Wang Y, Yue W, Xu X, Wei X, Zhu J, Huang X, Pei X. Infusion of megakaryocytic progenitor products generated from cord blood hematopoietic stem/progenitor cells: results of the phase 1 study. PLoS One. 2013;8(2):e54941. doi: 10.1371/journal.pone.0054941. Epub 2013 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Platelet recovery after infusion of MPs | Platelet recovery after infusion of MPs includes the time from infusion to platelet count=20×10^9/L,50×10^9/L,100×10^9/L. | 3 months | No |
Secondary | frequency of platelet infusion | 3 months | No | |
Secondary | incidence of acute toxicity | Acute toxicity mainly involves the heart,live and kidney. | 3 month | No |
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