AMLCLAGNCT05875649
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
An observational study of AML, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- AML
- What is being tested?
- CLAG
- How many people
- 137 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jul 2023to 20 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute myeloid leukemia patients don't achieve CR after first-induction chemotherapy.
Who may be able to join
- Acute myeloid leukemia patients with first-induction failure
Who cannot join
- Acute myeloid leukemia patients with serious infection and organ dysfunction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, 510515
Nanfang Hospital of Southern Medical University
Guanzhou, Guangdong, 510515
Xuejie Jiang, doctor, +8618688869522, jxj3331233@163.com
About this study
Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.
- Conditions
- AML
- Being tested
- CLAG
- Keywords
- CLAG, acute myeloid leukemia, First-induction failure
- 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.
CLAGCombination product
Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure
| Study group | Role | What they receive |
|---|---|---|
| Group | Acute myeloid leukemia patients with first-induction failure Receives: Combination Product: CLAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure
CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start2 Jul 2023 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 137 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuejie Jiang, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875649
- Sponsor's protocol ID
- NEFC-2023-162
- Acronym
- CLAG
- Status last verified
- Jul 2023
- First submitted
- 16 May 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: CLAG Regimen is used to re-induce acute myeloid leukemia patients after first-induction failure
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
- ClinicalTrials.gov ID
- NCT05875649
- Acronym / sponsor ID
- CLAG / NEFC-2023-162
- Conditions
- AML
- Keywords
- CLAG, acute myeloid leukemia, First-induction failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 2 Jul 2023 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 25 May 2023 (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.
Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Combination Product: CLAGAcute myeloid leukemia patients with first-induction failure |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute myeloid leukemia patients don't achieve CR after first-induction chemotherapy.
Key inclusion criteria (1 listed)
- Acute myeloid leukemia patients with first-induction failure
Key exclusion criteria (1 listed)
- Acute myeloid leukemia patients with serious infection and organ dysfunction.
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 |
|---|---|---|
| CLAGAcute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure | Combination product | Group |
Primary outcome
Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure
Time frame: 6 months
CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No. CLAG Regimen is used to re-induce acute myeloid leukemia patients after first-induction failure
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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.
Xuejie Jiang, Doctor study chair
Nanfang Hospital, Southern Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, run by Nanfang Hospital, Southern Medical University at 2 sites 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuejie Jiang, Doctor (+86 18688869522, jxj3331233@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure (time frame: 6 months). 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 5 Jul 2023.