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Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT02241031
Recruitment Status : Unknown
Verified September 2014 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
Sponsor:
Collaborators:
Guangdong General Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Peking University People's Hospital
Huazhong University of Science and Technology
Sun Yat-sen University
Academy Military Medical Science, China
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

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 with acute leukemia (AL).

Condition or disease Intervention/treatment Phase
Hematological Diseases Thrombocytopenia Biological: MPs Drug: thrombopoietin (TPO) and interleukin-11 Phase 2 Phase 3

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 unrelated donors, a constant shortage in the supply of platelets has become an important medical and society challenge. Therefore, investigation of alternative sources of platelets would be beneficial.

Hematopoietic stem cells (HSCs) can be used to generate functional megakaryocytic progenitors (MPs), megakaryocytes, and platelets on a large scale. Functional MPs and platelets have successfully been produced in vitro from CD34+ hematopoietic cells from bone marrow, cord blood, and peripheral blood. Several studies have reported that transplantation of in vitro auto-producing MPs can promote platelet recovery after high-dose therapy and HSC transplantation.

Umbilical cord blood is an abundant source of HSCs. In vitro large scale production of MPs from cord blood could represent an effective platelet substitute. Theoretically, the additional transplantation of ex vivo generated progenitor and post-progenitor cells might lead to the production of sufficient numbers of mature functional cells within a few days after transplantation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oprelvekin

Arm Intervention/treatment
Experimental: MPs
MPs will be intravenously infused within 48 hours after chemotherapy. During the study period, patients can receive platelet infusion but can not receive platelet stimulating factors.
Biological: MPs
MPs are generated from cord blood using a combination of cytokines.

Active Comparator: Non-MPs
Patients can receive platelet infusion but can not receive platelet stimulating factors.
Drug: thrombopoietin (TPO) and interleukin-11
Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.




Primary Outcome Measures :
  1. Platelet recovery after infusion of MPs [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. frequency of platelet infusion [ Time Frame: 3 months ]
  2. incidence of acute toxicity [ Time Frame: 3 month ]
    Acute toxicity mainly involves the heart,live and kidney.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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): NCT02241031


Contacts
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Contact: Ren Lin, MD +86-020-62787883 lansinglinren@hotmail.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Ren Lin, MD    +86-020-62787883    lansinglinren@hotmail.com   
Principal Investigator: Qifa Liu, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangdong General Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Peking University People's Hospital
Huazhong University of Science and Technology
Sun Yat-sen University
Academy Military Medical Science, China
Investigators
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Principal Investigator: Qifa Liu, MD Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02241031     History of Changes
Other Study ID Numbers: MPs-AL-2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Megakaryocytic Progenitor Products
Hematological Diseases
Thrombocytopenia

Additional relevant MeSH terms:
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Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders
Oprelvekin
Antineoplastic Agents