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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02241031 |
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Date of registration:
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13/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
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Scientific title:
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Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02241031 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Ren Lin, MD |
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Address:
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Telephone:
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+86-020-62787883 |
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Email:
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lansinglinren@hotmail.com |
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Affiliation:
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Name:
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Qifa Liu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nanfang Hospital of Southern Medical University |
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Name:
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Ren Lin, MD |
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Address:
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Telephone:
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+86-020-62787883 |
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Email:
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lansinglinren@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
14 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thrombocytopenia
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Hematological Diseases
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Intervention(s)
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Drug: thrombopoietin (TPO) and interleukin-11
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Biological: MPs
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Primary Outcome(s)
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Platelet recovery after infusion of MPs
[Time Frame: 3 months]
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Secondary Outcome(s)
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incidence of acute toxicity
[Time Frame: 3 month]
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frequency of platelet infusion
[Time Frame: 3 months]
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Secondary ID(s)
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MPs-AL-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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