Purpose

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.

Condition

Eligibility

Eligible Ages
Under 26 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Arm A (Retrospective data) Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.
  • Other: Questionnaire for patients receiving therapy
    Questionnaires will be given (at baseline, 1, 3, 6, and 12 months post CAR infusion) including baseline demographics, individual/family and neighborhood socioeconomic data, measures of household material hardship (housing and transportation insecurity, household energy and food insecurity), barriers to care at the CAR T cell institution, as well as patient reported outcomes following Kymriah infusion.
Arm B (Prospective data) Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire
  • Other: Questionnaire for patients receiving therapy
    Questionnaires will be given (at baseline, 1, 3, 6, and 12 months post CAR infusion) including baseline demographics, individual/family and neighborhood socioeconomic data, measures of household material hardship (housing and transportation insecurity, household energy and food insecurity), barriers to care at the CAR T cell institution, as well as patient reported outcomes following Kymriah infusion.

Recruiting Locations

Washington University in St. Louis and nearby locations

St. Louis Children's (Washington University)
St Louis 4407066, Missouri 4398678 63110
Contact:
Thomas Pfeiffer
pthomas@wustl.edu

More Details

NCT ID
NCT05865301
Status
Recruiting
Sponsor
Stanford University

Study Contact

Khanh Nguyen
(650) 721-2372
khanhpn@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.