Myelodysplastic SyndromesPhase 2/3NCT01417767
Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
A Phase 2/3 study testing CHG regimen and 5-aza-deoxycytidine in people with Myelodysplastic Syndromes, run by Xiao Li at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- CHG regimen and 5-aza-deoxycytidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200233
Xiao Li, lixiao3326@yahoo.com.cn
Xiao Li
About this study
Official title: Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
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).
Read the 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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- CHG regimen, 5-aza-deoxycytidine
- Keywords
- myelodysplastic syndromes, Decitabine, homoharringtonine, cytarabine, G-CSF
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHG regimenDrug
Also called Low dose chemotherapy
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.
5-aza-deoxycytidineDrug
Also called Dacogen
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.
| Study group | Role | What they receive |
|---|---|---|
| CHG regimen | Experimental | one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming) Receives: Drug: CHG regimen |
| Decitabine | Active comparator | one course of Decitabine (5-aza-deoxycytidine,Dacogen) Receives: Drug: 5-aza-deoxycytidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: four weeks after one course of CHG or two courses of Decitabine
Secondary outcomes (5)
overall survival
Measured: two years
overall remission rate
Measured: four weeks after one course of CHG or two courses of Decitabine
disease free survival
Measured: two years
hematology toxicities
Measured: within the first 4 weeks after CHG or Decitabine regimen
non-hematologic toxicities
Measured: within the first 4 weeks after CHG or Decitabine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Li, Shanghai 6th People's Hospital
- Investigators
- Xiao Li, Doctor, Study chair, Shanghai 6th People's HospitalLingyun Wu, Doctor, Study director, Shanghai 6th People's HospitalChunkang Chang, Doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417767
- Sponsor's protocol ID
- CHG-DAC 001
- Other IDs
- SHDC12010202
- Status last verified
- Sep 2011
- First submitted
- 15 Aug 2011
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
- ClinicalTrials.gov ID
- NCT01417767
- Acronym / sponsor ID
- CHG-DAC 001
- Conditions
- Myelodysplastic Syndromes
- Keywords
- myelodysplastic syndromes, Decitabine, homoharringtonine, cytarabine, G-CSF
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiao LiUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHG regimen | Experimental | Drug: CHG regimenone course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming) |
| Decitabine | Active comparator | Drug: 5-aza-deoxycytidineone course of Decitabine (5-aza-deoxycytidine,Dacogen) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHG regimenAlso: Low dose chemotherapycytarabine (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. | Drug | CHG regimen |
| 5-aza-deoxycytidineAlso: DacogenDecitabine (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. | Drug | Decitabine |
Primary outcome
complete remission rate
Time frame: four weeks after one course of CHG or two courses of Decitabine
5 secondary outcomes
overall survival
Time frame: two years
overall remission rate
Time frame: four weeks after one course of CHG or two courses of Decitabine
disease free survival
Time frame: two years
hematology toxicities
Time frame: within the first 4 weeks after CHG or Decitabine regimen
non-hematologic toxicities
Time frame: within the first 4 weeks after CHG or Decitabine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Li, Doctor study chair
Shanghai 6th People's Hospital
Lingyun Wu, Doctor study director
Shanghai 6th People's Hospital
Chunkang Chang, Doctor principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CHG regimen and 5-aza-deoxycytidine in people with Myelodysplastic Syndromes, run by Xiao Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Li, Doctor (008621-64369181-58745, lixiao3326@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: four weeks after one course of CHG or two courses of Decitabine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.