Second Infusion of Tisagenlecleucel for Children and Young Adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05460533

Provider View

This study is exploring whether a second, early infusion of the treatment tisagenlecleucel can help maintain a condition called B-Cell Aplasia in children and young adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL). Researchers are also examining the safety and effectiveness of this early reinfusion.

Patient Parameters

Program Overview

The purpose of this study is to determine if giving a second, early infusion of tisagenlecleucel can help keep patients in a state called B-Cell Aplasia six months after their first treatment. The study will also look at how safe this early reinfusion is and how well it works in treating B-ALL.

Description

Before the first infusion of tisagenlecleucel, patients need to receive a specific type of chemotherapy called lymphodepleting chemotherapy (LDC). This involves standard doses of the drugs cyclophosphamide and fludarabine. The chemotherapy should be completed 2 to 14 days before the first tisagenlecleucel infusion. If the infusion is delayed by more than 4 weeks, the chemotherapy may need to be repeated. However, no additional chemotherapy will be given before the early reinfusion of tisagenlecleucel.

Eligibility Criteria

Inclusion Criteria

  • Patients with relapsed or refractory B-ALL who have already received tisagenlecleucel and have more doses available for early reinfusion.
  • History of CD19 positive B-ALL before receiving tisagenlecleucel.
  • B-Cell Aplasia (BCA) in the blood within 14 days before reinfusion, defined as a B lymphocyte count of 50 or fewer per microliter.
  • Complete remission of the disease in the bone marrow within 14 days before reinfusion, including no disease outside the bone marrow.
  • Patients with tisagenlecleucel that is out of specification (OOS) can participate if the OOS reason does not affect the treatment's safety and effectiveness.
  • Patients must be under 26 years old at the time of the first tisagenlecleucel order.
  • Recovery from severe side effects of the initial tisagenlecleucel dose, such as cytokine release syndrome (CRS) and neurotoxicity.
  • Adequate organ function, including liver, kidney, heart, and lung function, as determined by specific medical tests.
  • Good overall health status, with specific performance scores based on age.
  • Enrollment in a related reporting protocol for immune effector cells.
  • Willingness to participate in the study, with informed consent signed by the patient or legal guardian, and assent from patients aged 7 to 17.

Exclusion Criteria

  • More than 60 days have passed since the first tisagenlecleucel infusion.
  • Ongoing severe side effects from the initial CAR T cell infusion.
  • Received non-standard chemotherapy before the first tisagenlecleucel dose.
  • Loss of B-Cell Aplasia before reinfusion.
  • Active, significant infection confirmed by medical tests.
  • Inability to give informed consent or follow the treatment plan.
  • Pregnant or breastfeeding women, or women who can become pregnant unless using effective birth control during and after treatment.
  • Sexually active males unless willing to use a condom during and after treatment.
  • Other uncontrolled illnesses or conditions that could interfere with the study or pose a risk to the patient.
  • Any other reason deemed by the doctor to make the patient ineligible for the study.

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