Phase 2 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:

Observational Arm (monitoring only, no assigned treatment):

• People with a type of blood cancer called ALL (acute lymphoblastic leukemia) who are undergoing a full-intensity stem cell transplant and still have detectable traces of cancer before the transplant (detected by a sensitive test called NGS-MRD).
• People under 1 year old with ALL who have no detectable traces of cancer before transplant (NGS-MRD negative).
• People with ALL who have no detectable traces of cancer before transplant, who are in their first or second remission, and who previously received a drug called inotuzumab ozogamicin.
• People with ALL who have no detectable traces of cancer before transplant and are receiving a specific type of transplant from a half-matched family donor (called a haploidentical transplant).
• People with ALL who have no detectable traces of cancer before transplant, are in their second remission, and whose cancer previously spread to the central nervous system (brain/spinal fluid).
• People with ALL who are beyond their second remission before transplant and were previously treated with a drug called blinatumomab.
• People with ALL who are beyond their second remission before transplant and previously received a type of immune cell therapy called CAR-T.
• People with ALL who have no detectable traces of cancer before transplant and are in their third remission or beyond.
• People with a type called T-ALL or MPAL who are having their first allogeneic (donor) stem cell transplant.
• People who would otherwise meet the criteria for the treatment arm but whose family has not agreed to the treatment arm, or whose treating doctor considers the observational arm to be in their best interest.

Treatment Arm:

• People with B-ALL (a specific type of ALL) who have no detectable traces of cancer before transplant (NGS-MRD negative).
• People aged 1 to 25 years old.
• People whose cancer is in their first or second remission (CR1 or CR2).
• People who have not previously had a donor stem cell transplant.
• People in their first or second remission after being treated with blinatumomab or CAR-T therapy.
• People who score at least 60% on a standard health and activity scale used before transplant (confirm with trial site).
• People who are able to give informed consent themselves (if over 18), or who have a parent or legal guardian able to give consent (if under 18).
• People whose lungs, kidneys, heart, and liver are working well enough, as measured by specific tests done within 4 weeks before starting the preparative treatment (confirm with trial site for exact thresholds).

Who may not be able to join:

• People in their second remission (CR2) whose cancer previously spread to the central nervous system (brain/spinal fluid) — these people may still be eligible for the observational arm.
• People who previously received a drug called inotuzumab ozogamicin — these people are not eligible for the treatment arm due to a risk of a serious liver complication, but may still be eligible for the observational arm.
• People who received a lower-intensity type of transplant conditioning (called non-myeloablative conditioning) — note that a specific reduced-toxicity approach called Flu/Mel/Thio is still allowed on the observational arm (confirm with trial site).
• People who are pregnant or breastfeeding, as some medications used in this trial may be harmful to unborn children or infants.
• People with HIV, or with a fungal, bacterial, or viral infection that is not under control — people who had a fungal infection during earlier treatment may still be considered if their infection responded well to treatment (confirm with trial site).
• People who have active leukemia in the brain/spinal fluid or other sites outside the bone marrow at the time of joining the trial.
• People with T-ALL or MPAL — these people are only eligible for the observational arm, not the treatment arm.
• People with certain inherited genetic conditions associated with bone marrow failure that carry a known poor outcome, such as Fanconi Anemia, Kostmann Syndrome, or Dyskeratosis Congenita.

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