NCT02241031

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

September 13, 2014

Last Update Submit

September 15, 2014

Conditions

Hematological DiseasesThrombocytopenia

Keywords

Megakaryocytic Progenitor ProductsHematological DiseasesThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • frequency of platelet infusion

    3 months

  • incidence of acute toxicity

    3 month

Study Arms (2)

MPs

EXPERIMENTAL

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

Non-MPs

ACTIVE COMPARATOR

Patients can receive platelet infusion but can not receive platelet stimulating factors.

Drug: thrombopoietin (TPO) and interleukin-11

Interventions

MPsBIOLOGICAL

MPs are generated from cord blood using a combination of cytokines.

MPs
thrombopoietin (TPO) and interleukin-11DRUG

Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.

Non-MPs

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23390507BACKGROUND

MeSH Terms

Conditions

Hematologic DiseasesThrombocytopenia

Interventions

ThrombopoietinInterleukin-11

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood Platelet DisordersCytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterleukins

Study Officials

  • Qifa Liu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Lin, MD

CONTACT

+86-020-62787883lansinglinren@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

CN(1)