Phase 2 Leukaemia Trial, Recruiting NCT05365035 Sponsor: M.D. Anderson Cancer Center Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05365035
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:

  • Adults aged 18 or older
  • People diagnosed with a blood/bone marrow condition called MDS (myelodysplastic syndrome) or CMML (chronic myelomonocytic leukaemia) or MDS/MPN (a related overlap condition), confirmed using standard medical classification — with eligibility depending on which of the following groups applies:
    • Group A: MDS with a higher-risk score (IPSS-R above 3.5) and more than 5% abnormal cells (blasts), where a standard type of treatment (HMA therapy) did not work after 6 cycles, or the condition came back or got worse at any point
    • Group B: CMML (type 1 or 2) where HMA therapy did not work after 6 cycles, or the condition came back or got worse at any point
    • Group C: MDS with a higher-risk score (IPSS-R above 3.5) and 10% or more abnormal cells, with no prior HMA treatment
    • Group D: CMML type 2, or CMML type 1 with at least one higher-risk feature such as disease outside the bone marrow, an enlarged spleen, low platelets, low haemoglobin, high white blood cell count, certain chromosome changes, or specific high-risk gene mutations — with no prior HMA treatment
    • Group E: A related overlap blood condition (MDS/MPN) with more than 5% abnormal cells, where HMA therapy did not work after 6 cycles, or the condition came back or got worse at any point
    • Group F: Certain MDS/MPN overlap conditions with no prior HMA treatment, where there are 10% or more abnormal cells, or more than 5% abnormal cells alongside higher-risk features (such as enlarged spleen, high white cell count, or specific genetic changes), or where HMA therapy is considered unlikely to help due to the nature of the disease
  • People with a general health/functioning score of 2 or less on a standard medical scale (ECOG), meaning able to carry out basic self-care even if not able to do all physical activity
  • People with kidneys working well enough (a clearance rate above 30 ml/min, as measured by a standard formula)
  • People with liver function within acceptable ranges for this trial (confirm with trial site for specific values)
  • People willing to follow all the rules and restrictions set out in the trial plan
  • People who have read and signed a consent form showing they understand what the trial involves and agree to take part
  • Both English-speaking and non-English-speaking people are eligible to participate

Who may not be able to join:

  • People with an active infection that is not responding adequately to antibiotic treatment
  • People with serious heart failure (classified as NYHA Class III or IV) or a heart pumping function below 50% on a heart scan
  • People who have had a heart attack in the past 6 months, or who have unstable or uncontrolled chest pain (angina), or a history of severe or uncontrolled irregular heart rhythms
  • People who are currently pregnant or breastfeeding
  • People who are capable of having children but are unwilling to use reliable contraception throughout the trial (specific contraception methods are listed in the trial protocol — confirm with trial site)
  • People who are capable of becoming pregnant but do not have a negative pregnancy test result (urine or blood test) at the start of the trial screening process
  • People currently receiving another experimental treatment, or any other chemotherapy, radiation therapy, or immunotherapy at the same time as this trial

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 12 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: Guillermo Bravo, MD, M.D. Anderson Cancer Center

Phone: (713) 794-3604

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
Registry
ClinicalTrials.gov
Start date
23 September 2022
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To establish the overall survival (OS).

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: 12 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