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Completed

NCT Number: NCT04775121

Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy, Villejuif, Val De Marne, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients with CMML:

  • 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
  • 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

Exclusion criteria

for patients with CMML:

  • 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
  • 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

Inclusion criteria

of age-matched healthy donors:

  • 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.

Exclusion criteria

of age-matched healthy donors:

  • 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

Treatment and study plan

Deuterium Glucose

Other

Oral administration of 20 g Deuterium Glucose on a 3-hour

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: MONOLIFE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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