Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the 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 at least 16 years old (Module 1; in the US, at least 18 years old) or at least 12 years old (Module 2)
• People who have been diagnosed with CD22-positive B-cell acute lymphoblastic leukemia (B-ALL), as defined by World Health Organization guidelines
• People whose B-ALL has come back after treatment or has not responded to treatment (with more than 5% blast cells in the bone marrow, or blast cells reappearing in the blood)
• People whose cancer falls into the specific type allowed by the module they are enrolling in — Module 1 accepts certain B-ALL types with or without a chromosome change called Philadelphia chromosome; Module 2 accepts B-ALL without the Philadelphia chromosome (confirm with trial site for which module applies)
• People with a performance status showing they are reasonably able to carry out daily activities (confirm with trial site for specific scoring details)
• People whose blast cell count in the blood is below 10,000 per microlitre before starting treatment (a procedure to reduce this count beforehand may be allowed under certain conditions)
• People who have already tried at least 2 prior treatments that did not work or stopped working, or at least 1 prior treatment with no remaining standard treatment options available — prior treatment targeting CD22 is also accepted
• People with the Philadelphia chromosome-positive type (Module 1 only) who cannot tolerate or have a medical reason to avoid a class of drugs called TKIs, or whose disease did not respond to at least 2 prior TKIs or at least one third-generation TKI
• People who received certain prior treatments within specified time periods before joining: donor lymphocyte infusion more than 4 weeks ago, prior cell therapy or autologous stem cell transplant more than 8 weeks ago, or donor stem cell transplant more than 12 weeks ago

Who may not be able to join:

• People diagnosed with Burkitt lymphoma or Burkitt leukemia
• People whose disease exists only outside the bone marrow, or who have active disease in the testicles or in the central nervous system beyond the earliest stage
• People who still have unresolved side effects from prior treatments rated at a moderate level or above (with some exceptions, such as hair loss, mild stable nerve symptoms, skin pigmentation changes, or hormone-related conditions controlled by treatment)
• People with a history of lung inflammation caused by a drug (not an infection) that required steroid tablets, steroid injections, or extra oxygen — or where lung inflammation cannot be ruled out by imaging at the screening stage
• People who have received certain other treatments too recently, including: chemotherapy within the past 14 days (with some exceptions); biological or immunotherapy treatments within the past 28 days or 5 half-lives (whichever is shorter); radiation therapy outside the brain within 2 weeks, or to the brain within 4 weeks; medications known to affect heart rhythm in a specific way (QTc prolongation) within 5 half-lives; certain drugs that strongly affect how the body processes other medications (strong CYP3A4 inhibitors) within 14 days or 5 half-lives (whichever is longer); or other experimental treatments within 30 days or 5 half-lives before the first dose of the study drug (specific rules apply depending on the type of prior experimental treatment — confirm with trial site)

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