NCT01417767

Brief Summary

The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).

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
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

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

First Submitted

Initial submission to the registry

August 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

August 15, 2011

Last Update Submit

September 8, 2016

Conditions

Myelodysplastic Syndromes

Keywords

myelodysplastic syndromesDecitabinehomoharringtoninecytarabineG-CSF

Outcome Measures

Primary Outcomes (1)

  • complete remission rate

    four weeks after one course of CHG or two courses of Decitabine

Secondary Outcomes (5)

  • overall survival

    two years

  • overall remission rate

    four weeks after one course of CHG or two courses of Decitabine

  • disease free survival

    two years

  • hematology toxicities

    within the first 4 weeks after CHG or Decitabine regimen

  • non-hematologic toxicities

    within the first 4 weeks after CHG or Decitabine

Study Arms (2)

CHG regimen

EXPERIMENTAL

one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)

Drug: CHG regimen

Decitabine

ACTIVE COMPARATOR

one course of Decitabine (5-aza-deoxycytidine,Dacogen)

Drug: 5-aza-deoxycytidine

Interventions

CHG regimenDRUG

cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L.

Also known as: Low dose chemotherapy
CHG regimen
5-aza-deoxycytidineDRUG

Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2.

Also known as: Dacogen
Decitabine

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age rang from 16 to 80 years;
  • diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow);
  • a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG);
  • no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases;
  • adequate hepatic (serum bilirubin level \<2×upper normal limit) and renal (serum creatinine \<2×upper normal limit) function tests.

You may not qualify if:

  • Female with pregnancy;
  • a performance of 4-5 according to ECOG score;
  • HIV positive;
  • uncontrolled severe fungal infection or tuberculosis;
  • with other progressive malignant diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Drug TherapyDecitabine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Xiao Li, Doctor

    Shanghai 6th People's Hospital

    STUDY CHAIR

  • Lingyun Wu, Doctor

    Shanghai 6th People's Hospital

    STUDY DIRECTOR

  • Chunkang Chang, Doctor

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Li, Doctor

CONTACT

008621-64369181-58745lixiao3326@yahoo.com.cn

Lingyun Wu, Doctor

CONTACT

008621-64369181-58336wu_lingyun@126.com

Study Design

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

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 16, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 9, 2016

Record last verified: 2011-09

Locations

CN(1)