Acute Myeloid LeukemiaNCT04373395
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
A study testing D-CLAG in people with Acute Myeloid Leukemia, run by Zhejiang University at 1 site in China.
Trial summary
A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- D-CLAG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Dec 2023
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification.
- Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells >5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before.
- Age 18-70.
- Eastern cancer cooperation group (ECOG) ≤2.
- Creatinine clearance ≥30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
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- Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50%.
- Life expectancy >8 weeks.
- Voluntarily sign the informed consent and understand and comply with the requirements of the study.
Who cannot join
- White blood cell (WBC) > 50 * 109 / L
- Patients who have received salvage treatment with D-CLAG.
- Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening.
- Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes).
- Pregnant or nursing women.
- Unable to understand or follow the research protocol or unable to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Yongxian Hu, Dr, 15957162012, huyongxian2000@aliyun.com
About this study
Official title: A Prospective, Single-arm, Multicenter, Exploratory Study to Evaluate the Efficacy and Safety of D-CLAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
- Conditions
- Acute Myeloid Leukemia
- Being tested
- D-CLAG
- 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.
D-CLAGProcedure or surgery
Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
| Study group | Role | What they receive |
|---|---|---|
| D-CLAG | Experimental | Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor) Receives: Procedure: D-CLAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
Complete remission rate after 1 course of D-CLAG regimen
Measured: Complete blood count recovery or 1 month after 1 course of D-CLAG regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (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.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, Zhejiang Provincial Tongde Hospital, Jinhua Central Hospital, Huizhou Municipal Central Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Hanhui Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373395
- Sponsor's protocol ID
- D-CLAG-ZJU
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter, Exploratory Study to Evaluate the Efficacy and Safety of D-CLAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04373395
- Acronym / sponsor ID
- D-CLAG-ZJU
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, Zhejiang Provincial Tongde Hospital, Jinhua Central Hospital, Huizhou Municipal Central Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Hanhui Pharmaceutical Co., Ltd
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 May 2020 (actual)
- 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.
A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D-CLAG | Experimental | Procedure: D-CLAGAdministration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification.
- Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells >5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before.
- Age 18-70.
- Eastern cancer cooperation group (ECOG) ≤2.
- Creatinine clearance ≥30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula).
Key exclusion criteria (6 listed)
- White blood cell (WBC) > 50 * 109 / L
- Patients who have received salvage treatment with D-CLAG.
- Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening.
- Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes).
- Pregnant or nursing women.
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 |
|---|---|---|
| D-CLAGDecitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor | Procedure or surgery | D-CLAG |
Primary outcome
Complete remission (CR) rate
Time frame: Complete blood count recovery or 1 month after 1 course of D-CLAG regimen
Complete remission rate after 1 course of D-CLAG regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-CLAG in people with Acute Myeloid Leukemia, run by Zhejiang 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 9 inclusion and 6 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 16 Sep 2020. 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.
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 Yongxian Hu (+86-0571-87236476, huyongxian2000@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) rate (time frame: Complete blood count recovery or 1 month after 1 course of D-CLAG regimen). 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 16 Sep 2020.