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

Lymphoid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05865301
• Other study ID #: IRB-70021
• Secondary ID: Gift Funding
• Status: Not yet recruiting
• Start date: August 30, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Khanh Nguyen
• Phone: (650) 721-2372
• Email: khanhpn[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Lymphoid Leukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Bass Center Leukemia Pilot Grant, Pediatric Oncology Experimental Therapeutics Investigators' Consort

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at baseline
Primary	Retrospective WECARE Survey	Surveys will be administered at a single time point post-CAR	up to 12 months post infusion
Secondary	overall survival (OS)	Overall survival was the duration from the start of study treatment to death.	at baseline up to 12 months post infusion
Secondary	event-free-survival (EFS)	probability of recurrence or progression of in patients	at baseline up to 12 months post infusion
Secondary	duration of remission (DOR)		at baseline up to 12 months post infusion