Status:
UNKNOWN
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hematological Diseases
Thrombocytopenia
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 wit...
Detailed Description
Thrombocytopenia is a common and potentially fatal complication of chemotherapy and hematopoietic stem cell transplantation. Owing to the short storage time and increased demand of platelets from unre...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02241031
Start Date
September 1 2014
End Date
December 1 2016
Last Update
September 16 2014
Active Locations (1)
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1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515