Phase 1 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 who are 18 years of age or older
• People who have a measurable amount of disease that can be tracked during the trial
• People with slow-growing (indolent) forms of non-Hodgkin lymphoma whose disease has reached a point where treatment is needed according to standard medical guidelines
• People with lymphoma that has changed into a more aggressive form may be eligible, except for certain specific subtypes listed under exclusions below
• People who are generally well enough to carry out normal daily activities with little or no limitation (this is measured on a standard scale; confirm with trial site for exact requirements)
• People whose organs (such as kidneys and liver) and bone marrow are functioning well enough to participate
• People of childbearing potential who are willing to use adequate contraception throughout the trial

For the early dose-finding phase (Phase 1a), people must also:

• Have a confirmed diagnosis of one of these blood cancers that has come back or stopped responding to treatment: CLL, SLL, WM, MCL, MZL, FL, DLBCL, or PCNSL
• Have already received at least 2 prior treatments (or at least 1 prior treatment for WM or PCNSL), with no other known beneficial treatment options remaining
• Currently need systemic (whole-body) treatment

For the later combination phase (Phase 1b), people must also:

• Have one of the following blood cancers that has returned or stopped responding, with specific prior treatment requirements for each:
• CLL or SLL that has stopped responding to a type of drug called a BTK inhibitor
• MCL that has stopped responding to both a BTK inhibitor and an anti-CD20 antibody-based treatment
• FL or MZL that has stopped responding to an anti-CD20 antibody-based treatment; or WM that has stopped responding to a BTK inhibitor
• PCNSL that has stopped responding to at least one prior treatment
• DLBCL that has stopped responding to an anti-CD20 antibody-based treatment and at least one other specific prior treatment regimen (confirm details with trial site)

Who may not be able to join:

• People with active, uncontrolled immune conditions where the body attacks its own red blood cells or platelets
• People with a history of most other autoimmune diseases (some exceptions apply, such as certain thyroid conditions, past childhood eczema, vitiligo, or hair loss — confirm with trial site)
• People who are unable to swallow capsules, or who have a condition that could affect how the study drug is absorbed or processed by the body
• People with bleeding disorders or other known risks of sudden blood loss
• People who are currently taking warfarin or a similar blood-thinning medication within 7 days before the first dose of the study drug
• People who have had radiation therapy within 2 weeks before the planned start of the study drug (routine limited palliative radiation may be an exception — confirm with trial site)
• People whose side effects from previous cancer treatments have not yet returned to normal or near-normal levels (some exceptions apply — confirm with trial site)
• People with another active cancer (an exception may apply for certain non-spreading skin cancers — confirm with trial site)
• People who have had major surgery requiring general anaesthesia within 4 weeks before the planned first dose of the study drug
• People with HIV, unless the infection is very well controlled with treatment (confirm with trial site)
• People with any currently active liver disease
• People with an active reactivation of certain viral infections such as CMV or EBV
• People taking high doses of corticosteroid medications (such as prednisone) above specified amounts within a set period before starting the study (exact limits differ depending on cancer type — confirm with trial site)
• People who have taken non-steroidal immune-suppressing drugs within 30 days before starting the study
• People with significant uncontrolled heart or cardiovascular disease, or who have had a heart attack within 6 months before the planned study start
• People who have taken certain medications that strongly affect how the body processes drugs (specific CYP3A or P-glycoprotein interacting medications) within a specified number of days before starting the study drug (confirm with trial site)

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