Phase 2 Leukaemia 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 aged 1 to 30 years old who have been diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma, where no other curative treatment options are available or have been declined.
• People with B-cell ALL whose disease has not responded to, or has progressed after, two lines of treatment (chemotherapy).
• People whose disease came back after achieving a complete remission (when no cancer was detectable).
• People with persistent or returning minimal residual disease (very small amounts of cancer cells still detectable by lab tests) confirmed on two separate occasions at least 4 weeks apart.
• People with a specific type of ALL called Philadelphia Chromosome positive ALL (Ph+ ALL), whose disease progressed, did not respond, or came back after two lines of treatment including targeted therapies called tyrosine kinase inhibitors.
• People with ALL that has returned in the central nervous system (brain/spinal fluid) after previously achieving complete remission.
• People with lymphoma whose disease progressed or came back after initial treatment that included specific types of chemotherapy (anthracycline) and a targeted antibody therapy (anti-CD20), and who have already tried or were not eligible for an autologous stem cell transplant (if relapse occurred 12 or more months after initial therapy).
• People whose cancer cells express a protein called CD19 on more than 50% of cancer cells (by one type of lab test) or at least 90% (by another type of lab test). If the person has previously received an anti-CD19 targeted therapy, CD19 expression must be confirmed again afterward.
• People who have previously had an autologous (own cells) stem cell transplant, if their disease has returned and other criteria are met.
• People who have previously had an allogeneic (donor cells) stem cell transplant, if it has been at least 100 days since the transplant, there is no active graft-versus-host disease (GVHD), and no immunosuppressive medications have been taken for at least 30 days.
• People who have previously received anti-CD19 or anti-CD22 CAR T-cell therapy, if very low levels of the previous CAR T cells remain in the blood (confirm with trial site).
• People who have measurable or evaluable disease at the time of enrollment.
• People whose most recent systemic treatment was at least 2 weeks ago (or 5 half-lives of that treatment, whichever is shorter) before the planned cell collection procedure; some exceptions apply for certain medications (confirm with trial site).
• People whose side effects from previous treatments have mostly resolved to a mild level (Grade 1 or lower), with some exceptions for minor or cosmetic side effects.
• People with acceptable blood counts: white blood cell component (ANC) of at least 750/uL, platelets of at least 50,000/uL, and lymphocytes of at least 150/uL — unless low counts are caused by the disease itself.
• People with adequate heart, kidney, liver, and lung function meeting specific lab and test thresholds.
• People with certain CNS (brain/spinal fluid) statuses related to leukemia or lymphoma, as long as there are no neurological symptoms, assessed according to specific medical classification criteria (confirm with trial site).
• People with a performance status of at least 50% on standard medical functioning scales (meaning able to carry out some daily activities with some assistance).
• People who are able to give informed consent; for those under 18, a parent or legal guardian must provide consent, and children over 7 years old will be asked for their agreement as well.
• People of childbearing or fathering potential who are willing to use contraception from enrollment through 4 months after receiving the preparative treatment.
• People who are female and of childbearing potential must have a negative pregnancy test before joining.

Who may not be able to join:

• People whose ALL is limited to a return of disease only in the testes.
• People with lymphoma or leukemia that has spread to the central nervous system (brain/spinal fluid) in a more advanced classification (CNS 3), or who have clinical signs of leukemia in the CNS.
• People with very high levels of leukemia cells in the blood (50,000 or more blast cells per microliter) or rapidly worsening disease that could prevent completing the study treatment.
• People with a history of another cancer (other than certain skin cancers or early-stage cancers such as those of the cervix, bladder, or breast) unless they have been cancer-free for at least 3 years.
• People with an active, uncontrolled infection requiring intravenous (IV) antibiotics or antifungal/antiviral medications; simple urinary tract infections or uncomplicated throat infections that are responding to treatment may be acceptable.
• People with an active HIV infection, active hepatitis B, or active hepatitis C; a past history of hepatitis B or C may be acceptable if the virus is undetectable on testing.
• People with certain neurological conditions such as stroke, dementia, cerebellar disease, or autoimmune disease affecting the brain, where assessing neurological side effects during the trial would be difficult.
• People with a significant heart condition in the past 12 months, such as a heart attack, unstable angina, or heart procedures, or those with lymphoma involving the heart.
• People currently taking blood-thinning (anticoagulation) medications.
• People with any other medical condition that the lead doctor believes would interfere with evaluating the safety or effectiveness of the treatment.
• People with a history of a severe allergic reaction to any medications used in this trial.
• People who are pregnant or breastfeeding, due to potential risks to the baby from the chemotherapy used to prepare the body for treatment.
• People who, in the investigator's judgment, are unlikely to complete all required visits or follow-up appointments.
• People with a primary immune deficiency or a history of a systemic autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required systemic immune-suppressing treatment within the last 2 years.

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