Phase 1 Lymphoma 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 have been diagnosed with B-cell acute lymphoblastic leukaemia (B-ALL) that has come back after treatment, with more than 5% leukaemia cells found in the bone marrow, with or without the disease spreading to other parts of the body.
• People whose leukaemia cells show a protein called CD22 on at least 20% of the cancer cells, confirmed by bone marrow or blood testing, or by a bone marrow biopsy.
• People who fall into one of these situations: their leukaemia has come back two or more times; it came back within 24 months of first being diagnosed; they are over 18 and have had any relapse; their disease did not respond to at least two rounds of initial chemotherapy (with or without one round of a drug called blinatumomab); or their leukaemia came back after a bone marrow transplant or CAR-T cell therapy.
• People with a specific type of leukaemia called Ph+ ALL who have already tried at least two prior treatments and have not responded to all available targeted medicines called tyrosine kinase inhibitors.
• People aged 1 year old up to (but not including) 40 years old at the time of joining the trial.
• People who are well enough to carry out at least half of their normal daily activities, as measured by standard medical scoring tools (confirm with trial site).
• People whose kidneys are working adequately, as measured by a standard kidney function test.
• People whose liver is working adequately, with bilirubin and liver enzyme levels within acceptable ranges (unless elevated levels are caused by the leukaemia itself).
• People who have or have had another separate cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People who have previously received a bone marrow transplant, provided at least 90 days have passed since the transplant, at least 30 days have passed since any donor lymphocyte infusion, they have had no more than one prior transplant, they show no signs of active graft-versus-host disease, and they have been off all anti-rejection medications for at least 28 days.
• People who have previously received CAR-T cell therapy targeting CD19 or CD22, provided at least 30 days have passed since the last infusion and CD22 is still present on at least 20% of leukaemia cells.
• People who have previously received a drug called inotuzumab ozogamicin, provided the total amount received was no more than 2.1 mg/m² and at least 90 days have passed since the last dose.
• People who have previously received a drug called venetoclax, provided at least 30 days have passed since the last dose.
• People who have waited the required amount of time since their last chemotherapy, antibody treatment, radiation, or other anti-cancer therapy before joining the trial (the specific waiting periods vary depending on the type of treatment received — confirm with trial site).

Who may not be able to join:

• People who have ever had a condition called sinusoidal obstruction syndrome (SOS), also known as veno-occlusive disease of the liver, regardless of how severe it was.
• People whose leukaemia has only come back in one isolated location outside the bone marrow, such as only in the central nervous system, only in the testes, or only in another single site.
• People who have a high level of leukaemia in the fluid around the brain and spinal cord (called CNS3 disease) at the time of joining, regardless of whether the bone marrow is also affected.
• People who are currently taking another experimental drug as part of a different trial.
• People who are currently receiving or planning to receive other anti-cancer treatments (with the exception of hydroxyurea or chemotherapy given directly into the spinal fluid).
• People who are currently taking medications to prevent graft-versus-host disease or organ rejection after a transplant, such as cyclosporine or tacrolimus, unless enough time has passed since the last dose (confirm with trial site).
• People known to have HIV, hepatitis B, or hepatitis C infections.
• People who have an active, uncontrolled infection, including a positive bacterial blood culture within 48 hours of joining, a documented infection with fever within 48 hours of joining, a positive fungal culture within 30 days of joining, or an active viral or parasitic infection requiring intravenous treatment.
• People known to have certain inherited conditions that affect bone marrow function, including Bloom syndrome, ataxia-telangiectasia, Fanconi anaemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.
• People who are pregnant, as a negative pregnancy test within 7 days before joining is required for anyone who could become pregnant.
• People who are breastfeeding, unless they agree to stop breastfeeding during treatment and for at least 2 months after the final dose.
• People who are sexually active and able to become pregnant, unless they agree to use effective contraception throughout the trial and for 8 months after the last dose.
• Male participants with female partners who could become pregnant, unless they agree to use effective contraception during treatment and for at least 5 months after the last dose.
• People who still have significant side effects (worse than mild) from a previous cancer treatment, except for hair loss.
• People who have had a serious allergic reaction to medicines that are chemically or biologically similar to venetoclax or inotuzumab ozogamicin.

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