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

NCT03045510 | Unknown Phase 2 DMC

• 1 other identifier: lower risk MDS-decitabine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Myelodysplastic Syndromes

Keywords

Decitabine Myelodysplastic syndrome

Outcome Measures

Primary Outcomes (1)

• complete response

  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.

  30 days from the emrollment

Study Arms (1)

Ultra small dose decitabine

EXPERIMENTAL

Decitabine 3.5mg/m2，ivdrip，qd x 5d, every four weeks for one cycle. It will be given six cycles.

Drug: decitabine

Interventions

decitabine DRUG

Decitabine 3.5mg/m2，ivdrip，qd x 5d, every four weeks for one cycle. It will be given six cycles.

Also known as: ultra small dose decitabine

Ultra small dose decitabine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (2)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Shandong University Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ming Lv, Doctor

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hou Ming

CONTACT

houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: December 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: July 30, 2020
• Last Updated: February 7, 2017

Record last verified: 2017-01

Locations

CN (2)