Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

Stanford University

Status: Enrolling

Conditions: Lymphoid Leukemia

Treatments: Other: Questionnaire for patients receiving therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05865301

NCI-2024-06344 (Registry Identifier)

Gift Funding (Other Identifier)

IRB-70021

Details and patient eligibility

About

To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Arm A)

* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma

Who either:

• Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.

OR

• Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or

  • Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.

Inclusion Criteria (Arm B)

• Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma

• Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age

• Patients who are either:

  • Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or
  • Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma

• Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects <18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those > 7 years of age, when appropriate, according to institutional procedures.

Trial design

500 participants in 2 patient groups

Arm A (Retrospective data)

Description:

Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.

Treatment:

Other: Questionnaire for patients receiving therapy

Arm B (Prospective data)

Description:

Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire

Treatment:

Other: Questionnaire for patients receiving therapy