Phase 2 Leukaemia Trial, Recruiting NCT04741945 Sponsor: Kirsten Grønbæk Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT04741945
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with a blood or bone marrow condition (main study group):

  • People diagnosed with low-risk Myelodysplastic Syndrome (a bone marrow condition where the bone marrow does not make enough healthy blood cells), classified as very low or low risk, with less than 5% abnormal cells in the bone marrow
  • People diagnosed with a condition called CCUS — where abnormal genetic changes are found in the blood, blood counts are persistently low for more than 6 months, and other causes have been ruled out, but the bone marrow does not show full signs of a bone marrow disease
  • Women who have gone through menopause, meaning women over 45 who have had no periods for at least 12 months, with no other medical explanation for this
  • People aged 18 or older
  • People who have given written consent to participate
  • People who are willing to follow the required parts of the study
  • People who are able to swallow pills

For healthy volunteers (comparison group):

  • Healthy individuals who are matched as closely as possible in age, sex, and body weight to the patients in the main study group
  • People who have given written consent to participate
  • People who are willing to follow the required parts of the study

Who may not be able to join:

For people with a blood or bone marrow condition (main study group):

  • People who have previously taken the medication metformin
  • People who have been diagnosed with diabetes
  • People who have received radiation therapy, immune-suppressing treatments (other than steroids), or chemotherapy within the past year
  • People who have received a specific white blood cell-boosting treatment (G-CSF) within the past 30 days
  • People who have previously been treated with certain bone marrow-targeting medications (azacitidine or decitabine)
  • People whose kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site)
  • People whose general physical functioning is significantly limited, based on a standard medical scale (confirm with trial site)
  • People who have had another active cancer within the past five years
  • People with serious uncontrolled health conditions, including poor liver function, chronic liver disease with serious complications, disabling mental health conditions, severe nerve or brain disease, uncontrolled metabolic conditions, or serious heart failure

For healthy volunteers (comparison group):

  • People who have used metformin within the past 3 years
  • People who have been diagnosed with diabetes, rheumatological conditions, autoimmune diseases, inflammatory conditions, coeliac disease, inflammatory bowel disease, or other gut-related conditions or symptoms
  • People who have received immune-suppressing medications (other than steroids) or chemotherapy within the past year, or antibiotics within the past 6 months
  • People for whom a specific type of body scan used in this study (MRS) is not safe or suitable (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Kirsten Grønbæk, Professor, MD, Rigshospitalet, Denmark

Phone: +45 35456060

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Kirsten Grønbæk
Registry
ClinicalTrials.gov
Start date
13 December 2021
Est. completion
1 February 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Safety as assessed by the number of serious adverse events including any suspected unexpected serious adverse reactions; Safety as assessed by median maximum tolerated dose in mg/day; Feasibility as assessed by rates of recruitment/refusal rates; Feasibility as assessed by 12 months follow-up, i.e., study completion, rate; Feasibility as assessed by rate of compliance to protocol procedures

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov