Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 with acute leukemia (AL).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Academy Military Medical Science, China; Guangdong General Hospital; Guangdong Provincial People's Hospital; Guangzhou First Municipal People’s Hospital; Guangzhou First 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
• Treatments: Oprelvekin

Criteria

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)