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Efficacy and Safety of Ultra Small Dose Decitabine for the Lower Risk MDS Patients With Transfusion Dependent

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ClinicalTrials.gov Identifier: NCT03045510
Recruitment Status : Unknown
Verified January 2017 by Ming Hou, Shandong University.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:

Myelodysplastic syndrome (MDS) is widely recognized as a clonal hematopoietic stem cell disorder. Decitabine has been approved for the treatment of all subtypes of myelodysplastic syndrome (MDS). However, the use of decitabine is often limited by its severe toxicity represented by myelosuppression even at relatively low doses. In lower-risk patients (including IPSS low and int-1 risk groups), treatment mainly aims at improving cytopenias, especially anemia. However, although several drugs may improve anemia, sometimes durably, most of lower risk MDS eventually require red blood cell (RBC) transfusions during their disease course. Long term RBC transfusions lead to iron overload mainly due to an increase in reticulo-endothelial iron recycling.Cardiac, liver and endocrine (diabetes mellitus) dysfunction due to iron overload and often leading to fatal outcome has been reported in heavily transfused lower risk MDS patients.

To date, the optimal regimen for decitabine treatment is not well established. In this study, we perform a prospective analysis to explore the decitabine schedule for the treatment of lower risk myelodysplastic syndrome patients with transfusion dependent.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: decitabine Phase 2

Detailed Description:
The investigators are undertaking a single-center, single-arm study of 50 lower risk myelodysplastic syndrome patients with transfusion dependent from Shandong University Qilu Hospital . All the participants are selected to receive ultra small dose decitabine treatment (given intravenously at a dose of 3.5mg/m2, qd x 5d, every four weeks for one cycle). A routine blood examination is performed twice every week. Bone marrow (BM) is examined with routine aspirate smear and G-banding analysis every 1-2 treatment courses to evaluate responses.Adverse events are also recorded throughout the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center Prospective Clinical Trial of the Efficacy and Safety of Ultra Small Dose Decitabine for the Lower Risk Myelodysplastic Syndrome Patients With Transfusion Dependent
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : July 30, 2020


Arm Intervention/treatment
Experimental: Ultra small dose decitabine
Decitabine 3.5mg/m2,ivdrip,qd x 5d, every four weeks for one cycle. It will be given six cycles.
Drug: decitabine
Decitabine 3.5mg/m2,ivdrip,qd x 5d, every four weeks for one cycle. It will be given six cycles.
Other Name: ultra small dose decitabine




Primary Outcome Measures :
  1. complete response [ Time Frame: 30 days from the emrollment ]
    Bone marrow blasts not more than 5%, absolute neutrophil count more than 1*10^9/L, HgB more than 100g/L, and platelet count more than 100*10^9/L.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of MDS
  • The IPSS [17] score ≤ 1
  • patients with transfusion dependent
  • Adequate hepatic and renal function (aspartate aminotransferase [AST] ≤ 2.5 x upper normal limit, alanine aminotransferase [ALT] ≤ 2.5 x upper normal limit, bilirubin ≤ 1.5 x upper normal limit and creatinine < 2 x upper normal limit, Ccr > 60ml/min ).

Exclusion Criteria:

  • Decitabine and Arsenic trioxide allergy
  • Pregnancy and lactation
  • Cardiovascular disease
  • ECOG score > 2
  • HCV, HIV, HBsAg seropositive status

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): NCT03045510


Contacts
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Contact: Hou Ming houming@medmail.com.cn

Locations
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China, Shandong
Qilu hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Shandong University Qilu Hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Lv         
Principal Investigator: Ming Hou, Dr         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Ming Lv, Doctor Shandong University
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03045510    
Other Study ID Numbers: lower risk MDS-decitabine
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ming Hou, Shandong University:
Decitabine Myelodysplastic syndrome
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors