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Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

Primary Purpose

Myelodysplastic Syndromes

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CHG regimen

5-aza-deoxycytidine

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring myelodysplastic syndromes, Decitabine, homoharringtonine, cytarabine, G-CSF

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shanghai 6th People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHG regimen

Decitabine

Arm Description

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

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

Outcomes

Primary Outcome Measures

complete remission rate

Secondary Outcome Measures

overall survival

overall remission rate

disease free survival

hematology toxicities

non-hematologic toxicities

Full Information

NCT ID

NCT01417767

First Posted

August 15, 2011

Last Updated

September 8, 2016

Sponsor

Xiao Li

1. Study Identification

Unique Protocol Identification Number

NCT01417767

Brief Title

Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

Official Title

Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiao Li

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes

Keywords

myelodysplastic syndromes, Decitabine, homoharringtonine, cytarabine, G-CSF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CHG regimen

Arm Type

Experimental

Arm Description

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

Arm Title

Decitabine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CHG regimen

Other Intervention Name(s)

Low dose chemotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

5-aza-deoxycytidine

Other Intervention Name(s)

Dacogen

Intervention Description

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.

Primary Outcome Measure Information:

Title

complete remission rate

Time Frame

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

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

two years

Title

overall remission rate

Time Frame

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

Title

disease free survival

Time Frame

two years

Title

hematology toxicities

Time Frame

within the first 4 weeks after CHG or Decitabine regimen

Title

non-hematologic toxicities

Time Frame

within the first 4 weeks after CHG or Decitabine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Li, Doctor

Phone

008621-64369181-58745

lixiao3326@yahoo.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Lingyun Wu, Doctor

Phone

008621-64369181-58336

wu_lingyun@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao Li, Doctor

Organizational Affiliation

Shanghai 6th People's Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lingyun Wu, Doctor

Organizational Affiliation

Shanghai 6th People's Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chunkang Chang, Doctor

Organizational Affiliation

Shanghai 6th People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai 6th People's Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200233

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiao Li

lixiao3326@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Xiao Li

12. IPD Sharing Statement

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Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS

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