B-Cell Acute Lymphoblastic Leukemia (B-ALL)NCT07048535
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
An observational study of B-Cell Acute Lymphoblastic Leukemia (B-ALL), run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19) -redirected chimeric antigen receptor (CAR) T-cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- B-Cell Acute Lymphoblastic Leukemia (B-ALL)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to Jul 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- ≤ 26-years old at the time of the first CAR treatment
- Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL
- Receipt of one unique CAR product (reinfusion of same product allowed)
- Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)
- Receipt of only one prior HCT (inclusive of pre- or post-CAR)
- ≥ 2-years post last CAR T-cell infusion
Who cannot join
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Aimee Talleur, MD, 888-226-4343, referralinfo@stjude.org
About this study
To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19)
-redirected chimeric antigen receptor (CAR) T-cells.
Read more
Primary Objective:
To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure.
Exploratory Objectives:
- To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL.
- To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy.
- To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy.
- To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.
Read the detailed description
Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients.
The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.
The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.
Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.
- Keywords
- B-Cell Acute Lymphoblastic Leukemia, B-ALL, Survivorship
- Medical subject headings
- Burkitt Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Estimation of participation rate
Measured: Through study completion, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start24 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Acute Lymphoblastic Leukemia (B-ALL)Studies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Talleur, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048535
- Sponsor's protocol ID
- CONQUER
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
- ClinicalTrials.gov ID
- NCT07048535
- Acronym / sponsor ID
- CONQUER
- Keywords
- B-Cell Acute Lymphoblastic Leukemia, B-ALL, Survivorship
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 2 Jul 2025 (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 learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19)
-redirected chimeric antigen receptor (CAR) T-cells.
Primary Objective:
To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure.
Exploratory Objectives:
- To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL.
- To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy.
- To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy.
- To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.
Detailed description
Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients.
The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.
The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.
Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (6 listed)
- ≤ 26-years old at the time of the first CAR treatment
- Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL
- Receipt of one unique CAR product (reinfusion of same product allowed)
- Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)
- Receipt of only one prior HCT (inclusive of pre- or post-CAR)
Key exclusion criteria (1 listed)
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Time frame: Through study completion, approximately 5 years
Estimation of participation rate
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 29 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Aimee Talleur, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-Cell Acute Lymphoblastic Leukemia (B-ALL), run by St. Jude Children's Research Hospital at 1 site 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 6 inclusion and 1 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Aimee Talleur, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy (time frame: Through study completion, approximately 5 years). 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 29 Apr 2026.