Acute LeukemiaNCT04157569
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia
An observational study of Acute Leukemia, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Acute Leukemia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2019to 31 Dec 2029
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population include old AML patients with somatic mutations
Who may be able to join
- Written informed consent
- Male
- not pregnant female
- patients >=60 years old
- Diagnosis of acute leukemia
Who cannot join
- Pregnancy
- HIV positive
- patients >=100 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Navy General Hospital
Beijing, 100048
Liren Qian, M.D., +861066957676, qlr2007@126.com
About this study
Official title: Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia
This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL
Read the detailed description
This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .
- Conditions
- Acute Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of relapse(CIR)
cumulative incidence of relapse
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
overall survival (OS)
overall survival
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start5 Nov 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, MD, Study chair, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157569
- Sponsor's protocol ID
- NavyGHB-006
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia
- ClinicalTrials.gov ID
- NCT04157569
- Acronym / sponsor ID
- NavyGHB-006
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Nov 2019 (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.
This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL
Detailed description
This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population include old AML patients with somatic mutations
Key inclusion criteria (5 listed)
- Written informed consent
- Male
- not pregnant female
- patients >=60 years old
- Diagnosis of acute leukemia
Key exclusion criteria (3 listed)
- Pregnancy
- HIV positive
- patients >=100 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cumulative incidence of relapse(CIR)
Time frame: through study completion, an average of 1 year
cumulative incidence of relapse
1 secondary outcome
overall survival (OS)
Time frame: through study completion, an average of 2 years
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 25 Feb 2020.
Related trials for Acute Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Liren Qian, MD study chair
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by Navy General Hospital, Beijing 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 3 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: looking for participants now, as of the sponsor's last update on 25 Feb 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?
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 Liren Qian, MD (+861066957676, qlr2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of relapse(CIR) (time frame: through study completion, an average of 1 year). 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 25 Feb 2020.