Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia (MONOLIFE)
Primary Purpose
Myelomonocytic Leukemia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deuterium Glucose
Sponsored by
About this trial
This is an interventional other trial for Myelomonocytic Leukemia
Eligibility Criteria
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 consentent 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> 300umol/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
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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
Outcomes
Primary Outcome Measures
Bone marrow release
To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers
Secondary Outcome Measures
Full Information
NCT ID
NCT04775121
First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT04775121
Brief Title
Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia
Acronym
MONOLIFE
Official Title
Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelomonocytic Leukemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Deuterium Glucose
Intervention Description
Oral administration of 20 g Deuterium Glucose on a 3-hour
Primary Outcome Measure Information:
Title
Bone marrow release
Description
To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 consentent 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> 300umol/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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric SOLARY, MD-PhD
Phone
0142114211
Ext
+33
Email
eric.solary@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaud MOTREFF
Phone
0142114211
Ext
+33
Email
thibaud.motreff@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SOLARY, MD-PhD
Phone
0142114211
Ext
+33
Email
eric.solary@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Thibaud MOTREFF
Phone
0142114211
Ext
+33
Email
thibaud.motreff@gustaveroussy.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia
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