Optimizing fludarabine phosphate exposure to improve event‑free survival in children and young adults with B‑cell acute lymphoblastic leukemia receiving CAR‑T therapy

Join the trial

After consent, you become a participant in the influence trial. the trial aims to improve car t cell therapy for children and young adults with b‑cell acute lymphoblastic leukemia.

Randomization

The study assigns you to one of two groups: standard fludarabine exposure or targeted fludarabine exposure. this assignment is done by a computer system and you do not choose the group.

Baseline assessments

Before any treatment, you will undergo a series of tests. these include blood work, bone‑marrow examination, and other evaluations to confirm disease status and organ function.

The results are used to ensure it is safe for you to receive the study medications and the later car t cell infusion.

Fludarabine administration

You will receive fludarabine phosphate as an intravenous (iv) infusion. the dose is 40 mg per square meter of body‑surface area (mg/m2).

The medication is given through a vein over a short period, according to the trial schedule. the purpose is to reduce (lymphodeplete) certain immune cells so that the later car t cells can expand effectively.

The exact number of days of fludarabine dosing follows the protocol and is the same for all participants in your assigned group.

Car t cell infusion

After fludarabine, you will receive the engineered car t cells by iv infusion. this is a single infusion administered in the hospital.

The infusion marks day 0 of post‑infusion monitoring.

Early monitoring (day 0‑28)

For the first four weeks after the infusion, you will stay in the hospital or return frequently for observation.

Medical staff will check for signs of response, side effects such as cytokine release syndrome (crs) or neurotoxicity (icans), blood counts, and infections.

Assessment at day 28

On day 28, a formal evaluation is performed to determine whether you have achieved a response.

The assessment includes blood and bone‑marrow tests to see if leukemia cells are absent and whether b‑cell aplasia (absence of normal b cells) is present.

Ongoing monitoring (day 28‑180)

For the next five months, you will have regular visits to monitor for late side effects, including severe cytopenia (low blood cell counts) and infections.

The study records the duration of b‑cell aplasia, the number of circulating car t cells, and any serious adverse events.

Long‑term follow‑up (up to 2 years)

After the 180‑day period, follow‑up visits continue for up to two years.

These visits assess disease relapse, need for additional anti‑leukemic therapy, overall survival, and patient‑reported outcomes.

Blood tests and clinical evaluations are performed at scheduled intervals, including a check at one year for b‑cell aplasia and car t cell persistence.