Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia

NCT04775121 | Completed

• 2 other identifiers: 2018-A01882-532018/2774
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Myelomonocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Bone marrow release

  To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers

  up to 30 days

Study Arms (2)

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

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

Other: Deuterium Glucose

Interventions

Deuterium Glucose OTHER

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

Experimental; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (2)

Gustave Roussy

Villejuif, Val De Marne, 94800, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: May 13, 2019
• Primary Completion: November 4, 2023
• Study Completion: November 4, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

FR (2)