Lymphoid LeukemiaNCT05865301
Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
An observational study of Lymphoid Leukemia, run by Stanford University at 22 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 26 years
- Conditions the study is for
- Lymphoid Leukemia
- What is being tested?
- Questionnaire for patients receiving therapy
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Jun 2023to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21231
Stacy Cooper, scoope30@jhmi.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Susanne Baumeister, susanne_baumeister@dfci.harvard.edu
- Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28262
Jeffrey Huo, Jeffrey.Huo@atriumhealth.org
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Kevin McNerney, kmcnerney@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Christine Phillips, christine.phillips@cchmc.org
Christa Krupski, christa.krupski@cchmc.org
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75235
Samuel John, samuel.john@utsouthwestern.edu
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Lindsey Murphy, lmurphy@coh.org
- Recruiting
Saint Jude Children's Research Hospital
Fairfax, Virginia, 22203
Swati Naik, swati.naik@stjude.org
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Holly Pacenta, holly.pacenta@cookchildrens.org
- Recruiting
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
John Ligon, john.ligon@ufl.edu
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Troy Quigg, troy.quigg@corewellhealth.org;
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Amy Moskop, amoskop@mcw.edu
- Recruiting
Nemours Children's Hospital
New Castle, Delaware, 19803
Ellen Fraint, Ellen.Fraint@nemours.org
- Recruiting
Stanford University
Palo Alto, California, 94305
Khanh Nguyen, 650-721-2372, khanhpn@stanford.edu
Kara Davis, MD
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Randy Windreich, Randy.Windreich@chp.edu
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Bill Chang, MD, changb@ohsu.edu
BIll Chang, MD
- Recruiting
UCSF (Benioff Children's)
San Francisco, California, 94115
William Temple, william.temple@ucsf.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Anurekha Hall, Anurekha.Hall@seattlechildrens.org
- Recruiting
St. Louis Children's (Washington University)
St Louis, Missouri, 63110
Thomas Pfeiffer, pthomas@wustl.edu
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Natalie Booth, nbooth3@jh.edu
- Recruiting
Children's Hospital at Montefiore
The Bronx, New York, 10467
David Loeb, david.loeb@einsteinmed.edu
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Laurel Truscott, ltruscott@peds.arizona.edu
About this study
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.
- Conditions
- Lymphoid Leukemia
- Being tested
- Questionnaire for patients receiving therapy
- Keywords
- PRWCC, Foresight
- Medical subject headings
- Leukemia, Lymphoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire for patients receiving therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Retrospective data) | Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes. Receives: Other: Questionnaire for patients receiving therapy | |
| Arm B (Prospective data) | Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire Receives: Other: Questionnaire for patients receiving therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline
Retrospective WECARE Survey
Surveys will be administered at a single time point post-CAR
Measured: up to 12 months post infusion
Secondary outcomes (3)
overall survival (OS)
Overall survival was the duration from the start of study treatment to death.
Measured: at baseline up to 12 months post infusion
event-free-survival (EFS)
probability of recurrence or progression of in patients
Measured: at baseline up to 12 months post infusion
duration of remission (DOR)
Measured: at baseline up to 12 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start29 Jun 2023
- Primary completionApr 2027 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
- Responsible party
- Sponsor
- Investigators
- Kara Davis, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865301
- Sponsor's protocol ID
- IRB-70021
- Other IDs
- NCI-2024-06344
- Status last verified
- Jun 2026
- First submitted
- 1 May 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
- ClinicalTrials.gov ID
- NCT05865301
- Acronym / sponsor ID
- IRB-70021
- Conditions
- Lymphoid Leukemia
- Keywords
- PRWCC, Foresight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Retrospective data) | – | Other: Questionnaire for patients receiving therapyParticipants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes. |
| Arm B (Prospective data) | – | Other: Questionnaire for patients receiving therapyPatients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire |
Who may qualify
- Ages
- Up to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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
Key inclusion criteria (12 listed)
- Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
- 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
- Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire for patients receiving therapyQuestionnaires 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. | Other | Arm A (Retrospective data), Arm B (Prospective data) |
Primary outcome
WECARE-Survey
Time frame: at baseline
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)
Retrospective WECARE Survey
Time frame: up to 12 months post infusion
Surveys will be administered at a single time point post-CAR
3 secondary outcomes
overall survival (OS)
Time frame: at baseline up to 12 months post infusion
event-free-survival (EFS)
Time frame: at baseline up to 12 months post infusion
duration of remission (DOR)
Time frame: at baseline up to 12 months post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara Davis, MD principal investigator
Stanford University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoid Leukemia, run by Stanford University at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khanh Nguyen ((650) 721-2372, khanhpn@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WECARE-Survey (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.