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Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02883036
Recruitment Status : Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaoli Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML. As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and nilotinib have more potent anti-leukemic activity and less side-effect. However, acquired resistance to TKIs is one of the main obstacles to effective CML treatment and is involved in gene amplication of ABL tyrosine kinase point mutations. The outcomes of patients with these ABL tyrosine kinase point mutations have linked to worse prognosis and higher mortality generally. Metabolic adaptations are common in cancer cells, and cancer cells become more dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum antibiotics, inhibits mitochondrial biogenesis as its an interesting "side-effect".In recent study,researchers indicated that tigecycline can eradicate cancer stem cells by targeting mitochondrial.Here, the investigators test tigecycline's anti-leukemic activity to chronic myeloid leukemia in vitro.

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Other: blood sampling

Detailed Description:
In this study, the investigators collected bone marrow(BM) or/and peripheral blood(PB) mononuclear cells from patients with chronic myeloid leukemia.Patients could be in different stages of chronic myeloid leukemia pre-treatment.Additionally, the investigators also selected some healthy volunteers as comparison.Firstly, the investigators analyzed mitochondrial biogenesis and basal metabolic characteristic of mononuclear cells from patients and healthy volunteers.Secondly, the investigators tested the cell viability and apoptosis after tigecycline treatment.Thirdly,the investigators detected the changes of cell mitochondrial biogenesis and metabolic characteristic in the same study sample after tigecycline stimulation. Finally,the investigators analyzed the correlation between sensitivities of mononuclear cells to tigecycline and patients' clinical parameters and survival outcome.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes of Mitochondrial Biogenesis and Metabolic Characteristics About Tigecycline to Treat Chronic Myeloid Leukemia in Vitro
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021


Group/Cohort Intervention/treatment
Patients with chronic myeloid leukemia
100 adult patients(age>18 years),with chronic myeloid leukemia defined by the World Health Organization(WHO) criteria
Other: blood sampling
sampling after diagnosis and the mononuclear cells will be given tigecycline stimulation in vitro

Healthy volunteers
Healthy volunteers
Other: blood sampling
sampling after register and the mononuclear cells will be given tigecycline stimulation in vitro




Primary Outcome Measures :
  1. mitochondrial biogenesis and metabolic characteristics of Bone Marrow(BM)/ Peripheral Blood(PB) mononuclear cells [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. mitochondrial biogenesis and metabolic characteristics of BM/PB mononuclear cells after tigecycline stimulation [ Time Frame: After Hour 24 and 48 tigecycline stimulation ]
  2. cell viability and apoptosis of BM/PB mononuclear cells after tigecycline stimulation [ Time Frame: After Hour 24 and 48 tigecycline stimulation ]
  3. Patients' clinical characteristics and survival outcomes [ Time Frame: Through study completion, an average of 1 year ]

Biospecimen Retention:   Samples With DNA
mononuclear cells of bone marrow and/or peripheral blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 adults patients with chronic myeloid leukemia
Criteria

Inclusion Criteria:

  • Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
  • Age >18 years.
  • Eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the Principal Investigator

Exclusion Criteria:

  • Patients may not receive any other antibiotics.
  • Patients may not have received prior treatment with TKIs or hydroxyurea.
  • Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
  • No prior malignancies or any other cancer from which patient has been disease free for 5 years.

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): NCT02883036


Contacts
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Contact: Xiaoli Liu, MD 86-020-61641616 lxl2405@126.com
Contact: Na Xu, MD 86-020-61641615 292347668@qq.com

Locations
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China, Guangdong
Department of hematology,Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Contact: Xiaoli Liu, MD    86-020-61641616    lxl2405@126.com   
Contact: Na Xu, MD    86-020-61641615    292347668@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Publications:
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Responsible Party: Xiaoli Liu, professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02883036    
Other Study ID Numbers: VSTICML-01
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xiaoli Liu, Nanfang Hospital of Southern Medical University:
tigecycline
treatment
mitochondrial biogenesis
metabolic characteristics
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases