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

ConditionLymphoid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 26
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Questionnaire for patients receiving therapy

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Arm A (Retrospective data)1 intervention
Group B: Arm B (Prospective data)1 intervention

Trial outcomes

Primary outcomes

1

WECARE-Survey

Participant will take part in a one-time questionnaire to address CAR specific questions. WECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language)

Time frame
at baseline
2

Retrospective WECARE Survey

Surveys will be administered at a single time point post-CAR

Time frame
up to 12 months post infusion

Secondary outcomes

1

overall survival (OS)

Overall survival was the duration from the start of study treatment to death.

Time frame
at baseline up to 12 months post infusion
2

event-free-survival (EFS)

probability of recurrence or progression of in patients

Time frame
at baseline up to 12 months post infusion
3

duration of remission (DOR)

Time frame
at baseline up to 12 months post infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

The Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Collaborator

Source ClinicalTrials.gov
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