Myelomonocytic LeukemiaMONOLIFENCT04775121
Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia
A study testing Deuterium Glucose in people with Myelomonocytic Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
Trial summary
To measure the rate of bone marrow release and the lifespan of classical monocytes in the peripheral blood of patients with a chronic myelomonocytic leukemia Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelomonocytic Leukemia
- What is being tested?
- Deuterium Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesFrance
- Study dates
- 13 May 2019to 4 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 18 years or over
- CMML diagnosis according to the WHO 2016 criteria
- Untreated patient or patient who did not receive a cytoreductive drug such as Hydroxyurea or an Erythropoiesis Stimulating Agent (ESA), or a growth factor, or Eltrombopag within the last 2 months or patient who did not receive a hypomethylating drug (Azacytidine or Decitabine) within the last 3 months
- Affiliated to a social security system or beneficiary of the same
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Able to comprehend the Information Sheet and willing to give written informed consent prior to any protocol-specific procedures performed
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- Willing to allow the Investigator to review data from the hospital medical records
- For women of child-bearing age only, willingness to practice continuous effective contraception during the study. Women of childbearing potential must have a negative urine β-HCG pregnancy test within 15 days prior to the first administration of deuterium-labeled glucose. Sexually active male patients must agree to use condoms during the study. Also, it is recommended their women of childbearing potential partner use an effective method of contraception during the same period
- Volunteers aged 55 years or over
- Able and willing to comply with all study requirements
- Able to comprehend the Information Sheet and willing to give written informed consent prior to any protocol-specific procedures performed
- For women of child-bearing age only, willingness to practice continuous effective contraception during the study. Women of childbearing potential must have a negative urine β-HCG pregnancy test within 15 days prior to the first administration of deuterium-labeled glucose. Sexually active male patients must agree to use condoms during the study. Also, it is recommended their women of childbearing potential partner use an effective method of contraception during the same period.
Who cannot join
- Severe anemia (Hb < 10 g/dL)
- Severe thrombocytopenia (Platelets < 50 G/L)
- Transfusion dependency
- Active or recent infection or febrile illness (<1 month)
- Currently active inflammatory or autoimmune condition
- Current systemic steroid therapy or other immunomodulatory drugs
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- Recent vaccination (< 1 month)
- Recent surgery (< 1 month)
- Active malignant disease
- Renal disease (serum creatinine> 300µmol/L)
- Hepatic disease (transaminase levels >3x ULN)
- Severe or unstable cardiovascular disease
- Pregnancy or breastfeeding
- Other current active medical condition which the Investigator considers a risk for entry in the study
- Simultaneous participation in another concurrent research study that conflicts e.g. if it also involves blood sampling
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Current treatment for any type of disease
- Current active medical condition
- Recent vaccination (< 1 month)
- Recent surgery (< 1 month)
- Pregnancy or breastfeeding
- Simultaneous participation in another concurrent research study that conflicts e.g. if it also involves blood sampling
- Subject under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Saint Louis
Paris, 75010
Gustave Roussy
Villejuif, Val De Marne, 94800
About this study
To measure the rate of bone marrow release and the lifespan of classical monocytes in the peripheral blood of patients with a chronic myelomonocytic leukemia
- Conditions
- Myelomonocytic Leukemia
- Being tested
- Deuterium Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium GlucoseOther
Oral administration of 20 g Deuterium Glucose on a 3-hour
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Oral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time Receives: Other: Deuterium Glucose |
| Healthy volunteers | Experimental | Oral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time Receives: Other: Deuterium Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow release
To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start13 May 2019
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelomonocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Deuterium glucose ingestion on a 3-hour period to label rapidly proliferating cells, followed by sequential collection of sorted classical monocytes on a 30-day period
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775121
- Sponsor's protocol ID
- 2018-A01882-53
- Other IDs
- 2018/2774
- Acronym
- MONOLIFE
- Status last verified
- May 2024
- First submitted
- 23 Feb 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT04775121
- Acronym / sponsor ID
- MONOLIFE / 2018-A01882-53
- Conditions
- Myelomonocytic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 1 Mar 2021 (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.
To measure the rate of bone marrow release and the lifespan of classical monocytes in the peripheral blood of patients with a chronic myelomonocytic leukemia
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Deuterium glucose ingestion on a 3-hour period to label rapidly proliferating cells, followed by sequential collection of sorted classical monocytes on a 30-day period
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Deuterium GlucoseOral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time |
| Healthy volunteers | Experimental | Other: Deuterium GlucoseOral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult aged 18 years or over
- CMML diagnosis according to the WHO 2016 criteria
- Untreated patient or patient who did not receive a cytoreductive drug such as Hydroxyurea or an Erythropoiesis Stimulating Agent (ESA), or a growth factor, or Eltrombopag within the last 2 months or patient who did not receive a hypomethylating drug (Azacytidine or Decitabine) within the last 3 months
- Affiliated to a social security system or beneficiary of the same
- Able and willing (in the Investigator's opinion) to comply with all study requirements
Key exclusion criteria (23 listed)
- Severe anemia (Hb < 10 g/dL)
- Severe thrombocytopenia (Platelets < 50 G/L)
- Transfusion dependency
- Active or recent infection or febrile illness (<1 month)
- Currently active inflammatory or autoimmune condition
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 |
|---|---|---|
| Deuterium GlucoseOral administration of 20 g Deuterium Glucose on a 3-hour | Other | Experimental, Healthy volunteers |
Primary outcome
Bone marrow release
Time frame: up to 30 days
To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deuterium Glucose in people with Myelomonocytic Leukemia, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
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 12 inclusion and 23 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: finished, as of the sponsor's last update on 24 May 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone marrow release (time frame: up to 30 days). 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 24 May 2024.