Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People with a type of blood cancer called AML (acute myeloid leukemia, but not a specific subtype called acute promyelocytic leukemia) that has come back or stopped responding to treatment, and where no standard treatments with proven benefit remain available.
• People in the early phase of the trial may also be eligible if they have a higher-risk form of a blood disorder called myelodysplastic syndrome (MDS) that has come back or stopped responding to treatment, and where no standard treatments with proven benefit remain available.
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scoring system (a score of 0, 1, or 2 on the ECOG scale).
• People whose side effects from any previous treatments have mostly resolved to a mild level or better (with the exception of hair loss).
• People who have previously had a stem cell or bone marrow transplant using their own cells (autologous) or donor cells (allogeneic) may be considered eligible.
• People who received a donor bone marrow transplant may be considered, provided the transplant was done more than 120 days before starting the trial treatment, there is no active transplant rejection reaction (graft versus host disease) at grade 1 or above, and all anti-rejection medications have been stopped for at least 2 weeks before starting treatment (low-dose steroids, equivalent to 20mg prednisone or less, may be permitted if not being used to manage the transplant or rejection reactions).
• People whose kidneys and liver are functioning adequately, as confirmed by specific blood test results meeting defined thresholds (confirm with trial site for exact values).

Who may not be able to join:

• People who have previously received any treatment that targets a protein called CD37.
• People with a currently active infection, including active hepatitis B or C, HIV, cytomegalovirus, or any other active infectious disease that the trial doctor considers would make participation unsuitable.
• People who have had significant heart problems in the 6 months before enrolling, including severe heart failure, uncontrolled chest pain, a heart attack, serious irregular heart rhythms, or an abnormal heart electrical reading (QTcF interval above 470 ms).
• People with currently active and clinically significant heart or lung disease.
• People with another active cancer, with two exceptions: other blood cancers not being treated with active cancer therapy, or non-blood cancers that are in remission and where all cancer treatments were completed at least 6 months before starting the trial and side effects have resolved to a mild level or better.
• People with signs that their leukemia has spread to the brain or spinal fluid (central nervous system), unless a prior history of this has been followed by at least two clear spinal fluid tests and brain scans showing no remaining disease.
• People with moderate or severe nerve damage (peripheral neuropathy at grade 2 or above).
• People with a known allergy or sensitivity to the trial drug (Debio 1562M) or any of its ingredients.
• People who have received cancer treatments — including chemotherapy, immunotherapy, radiation, hormonal therapy, biological therapy, or other experimental treatments — within the 14 days before starting the trial (or within 5 half-lives of the previous treatment, whichever is shorter). A medication called hydroxyurea may be permitted before and after starting the trial to manage high white blood cell counts.
• People who have had major surgery within 4 weeks before starting the trial, or who have not yet recovered from a recent surgery.
• People who are pregnant or breastfeeding.

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