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Trial Title:
Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
NCT ID:
NCT05865301
Condition:
Lymphoid Leukemia
Conditions: Official terms:
Leukemia, Lymphoid
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Questionnaire for patients receiving therapy
Description:
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 group label:
Arm A (Retrospective data)
Arm group label:
Arm B (Prospective data)
Summary:
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.
Criteria for eligibility:
Study pop:
Both Arm A and Arm B, includes retrospective and prospective data collection for patients
experiencing refractory disease or first relapse, who have not received immunotherapy and
are not yet being considered for immunotherapy. Retrospective data collection will
parallel Arm A and patients will not require consent or assent. Prospective data
collection will parallel Arm B and will require patient consent and assent as relevant
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
26 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Khanh Nguyen
Phone:
650-721-2372
Email:
khanhpn@stanford.edu
Start date:
June 29, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Collaborator:
Agency:
Pediatric Oncology Experimental Therapeutic Investigators Consortium
Agency class:
Other
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05865301
