Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
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
- Lymphoid Leukemia
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
Arm | Description | Assigned Intervention |
---|---|---|
Arm A (Retrospective data) | Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes. |
|
Arm B (Prospective data) | Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT05865301
- Status
- Recruiting
- Sponsor
- Stanford University