Acute Myeloid LeukemiaPhase 2NCT03045627
Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients
A Phase 2 study testing AraC, Aclarubicin and Peg-G-CSF in people with Acute Myeloid Leukemia, run by Shandong University at 1 site in China.
Trial summary
Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- AraC, Aclarubicin and Peg-G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jul 2020
- Phase
- Phase 2
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60 years and older, with an upper age limit of 75 years;
- diagnosis of AML other than APL
- Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin and creatinine < 2.5 x upper normal limit).
Who cannot join
- History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin
- Use of recreational drugs or history of drug addiction, within the prior 6 months
- Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies
- Patients with documented cases of human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
Ming Hou, Docter contact
China1 site, 1 recruiting
- Recruiting
Qilu hospital, Shandong University
Jinan, Shandong, 250012
Ming Hou, houming@medmail.com.cn
Ming Hou
About this study
Official title: A Multi-center Randomized Open-label Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of Acute Myeloid Leukemia Patients
Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).
Read the detailed description
The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- AraC, Aclarubicin, Peg-G-CSF, G-CSF
- Keywords
- Acute Myeloid Leukemia, PEG-G-CSF
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AraCDrug
Also called cytarabine
ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
AclarubicinDrug
Also called Aclarubicin A
Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8
Peg-G-CSFDrug
PEG-G-CSF 6mg subcutaneously on days 0.
G-CSFDrug
G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Ara-C, Aclarubicin Combined PEG-G-CSF
ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, PEG-G-CSF 6mg subcutaneously on days 0. One course includes 28 days. Receives: Drug: AraC; Drug: Aclarubicin; Drug: Peg-G-CSF |
| Active comparator | Active comparator | Ara-C, Aclarubicin Combined G-CSF
ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. G-CSF was postponed or interrupted in case of white blood cell (WBC) count greater than 20 × 109/L .
One course includes 28 days. Receives: Drug: AraC; Drug: Aclarubicin; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR)
Bone marrow blasts not more than 5%, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count more than 1*10^9/L, platelet count more than 100*10^9/L,independence of red cell transfusions
Measured: 60 days from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045627
- Sponsor's protocol ID
- AML- PEG-G-CSF
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Open-label Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT03045627
- Acronym / sponsor ID
- AML- PEG-G-CSF
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, PEG-G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Feb 2017 (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.
Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).
Detailed description
The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: AraC, Drug: Aclarubicin, Drug: Peg-G-CSFAra-C, Aclarubicin Combined PEG-G-CSF ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, PEG-G-CSF 6mg subcutaneously on days 0. One course includes 28 days. |
| Active comparator | Active comparator | Drug: AraC, Drug: Aclarubicin, Drug: G-CSFAra-C, Aclarubicin Combined G-CSF ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. G-CSF was postponed or interrupted in case of white blood cell (WBC) count greater than 20 × 109/L . One course includes 28 days. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60 years and older, with an upper age limit of 75 years;
- diagnosis of AML other than APL
- Adequate hepatic and renal function (aspartate aminotransferase [AST], alanine aminotransferase [ALT], bilirubin and creatinine < 2.5 x upper normal limit).
Key exclusion criteria (4 listed)
- History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin
- Use of recreational drugs or history of drug addiction, within the prior 6 months
- Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies
- Patients with documented cases of human immunodeficiency virus (HIV)
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 |
|---|---|---|
| AraCAlso: cytarabineARA-C subcutaneously in a 12-hour infusion on days 1 through 14 | Drug | Active comparator, Experimental |
| AclarubicinAlso: Aclarubicin AAclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8 | Drug | Active comparator, Experimental |
| Peg-G-CSFPEG-G-CSF 6mg subcutaneously on days 0. | Drug | Experimental |
| G-CSFG-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. | Drug | Active comparator |
Primary outcome
Complete remission (CR)
Time frame: 60 days from the enrollment
Bone marrow blasts not more than 5%, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count more than 1*10^9/L, platelet count more than 100*10^9/L,independence of red cell transfusions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ming Hou, Docter contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AraC, Aclarubicin and Peg-G-CSF in people with Acute Myeloid Leukemia, run by Shandong University 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 3 inclusion and 4 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 7 Feb 2017. 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 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.
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 Ming Hou, Docter (houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) (time frame: 60 days from the enrollment). 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 7 Feb 2017.