B-Cell ALLBOOSTERNCT07422337
A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
An observational study of B-Cell ALL and B-Cell Acute Lymphoblastic Leukaemia, run by Arkansas Children's Hospital Research Institute at 2 sites in United States.
Trial summary
The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. Read more about this study
- Who is it for?
- Ages 1 year to 23 years
- Conditions the study is for
- B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia, B-Cell Lymphoblastic Leukemia
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2026to Jan 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 1 year to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Potential participants will be identified through referrals and from medical records. Prospective participants are those who have been captured prior to starting chemotherapy, and retrospective participants are those who have been captured after starting chemotherapy or have finished chemotherapy within the previous 12 months.
Who may be able to join
- Diagnosis of B-lineage acute lymphoblastic leukemia/lymphoma
- ≥1 year old and up to 21 years old at diagnosis
- Informed consent provided, and if applicable, child assent provided
- Must have received all vaccinations routinely administered during first year of life
Who cannot join
- Relapsed/refractory disease at any time
- Received or will require a bone marrow transplant and/or cellular therapy
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie Thomas, RN contact
United States2 sites, 2 recruiting
- Recruiting
Arkansas Children's
Little Rock, Arkansas, 72202
Stephanie Thomas, RN, 501-364-3820, chamnesssl@archildrens.org
Lauren Appell, MD, 501-364-1494
- Recruiting
Arkansas Children's Northwest
Springdale, Arkansas, 72762
Cristyn Branstetter, MD, 479-770-5921, CBranstetter@uams.edu
Cristyn Branstetter, MD
About this study
Official title: Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. The main study aims are:
- Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL/Ly who have received blinatumomab.
- To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.
Researchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.
Read the detailed description
The most common form of malignancy in children is B-cell acute lymphoblastic leukemia (B-ALL). B-ALL is a type of blood cancer resulting from clonal expansion of an abnormal B-cell precursor known as a lymphoblast. Mature normal B-cells are white blood cells produced in the bone marrow that play a crucial role in fighting infections and in humoral immunity. Abnormal, immature B-cells begin to form and multiply quickly, crowding out healthy cells in the bone marrow. As these cancerous B-cells accumulate, they spill into the bloodstream and can spread (metastasize) throughout the body.
CD19 is the antigen expressed on the surface of nearly all B cells throughout all phases of maturation. CD19 expression plays a crucial role in the body's ability to mount an immune response against a pathogen. Through several studies, CD19 was found to be highly conserved among B-cell malignancies, making it an optimal target for B-ALL treatment. Blinatumomab is a bispecific T-cell engager (BiTE) that links the T-cell CD3 and B-cell CD19. This results in the activation, proliferation, and clonal expansion of T-cells resulting in destruction of the targeted CD19+ cells. Blinatumomab has been shown to improve outcomes among pediatric patients diagnosed with B-ALL significantly; and is now a part of the backbone of treatment for B-ALL.
A key concern for the pediatric population receiving blinatumomab is the potential loss of vaccine-induced immunity established before chemotherapy. Intensive chemotherapy in patients with B-cell acute lymphoblastic leukemia (B-ALL) can impair humoral immunity, leading to the loss of antibodies generated by previous vaccinations due to the depletion of memory B cells. Currently, there is no established protocol for revaccination in B-ALL patients treated with blinatumomab. However, prior studies involving other immunotherapeutic agents, such as CAR T-cell therapy, have shown that patients often exhibit low post-treatment antibody titers, necessitating booster doses or even full revaccination. Because blinatumomab has shown to improve outcomes in the vast majority of children with B-ALL, it is critical to determine the unknown long-term effects on humoral immunity in these patients.
Clinical practice regarding revaccination post-chemotherapy in the B-ALL population is widely variable. Children with leukemia who have undergone chemotherapy often experience prolonged immunosuppression, making them particularly vulnerable to vaccine-preventable diseases. The disease itself, combined with its treatment, causes significant immunosuppression-especially in acute lymphoblastic leukemia (ALL)-when compared to solid tumors. While partial immune recovery may occur approximately three months after chemotherapy, full recovery can take longer and depends on factors such as the patient's age, type of cancer, and the intensity of treatment received. In immunocompromised patients, live vaccines are generally considered to be unsafe, putting patients at high risk of viral reactivation. However, non-live (inactivated) vaccines are considered safe and effective. Therefore, it is essential to establish a clear vaccination protocol to protect this vulnerable population from preventable infections.
While standard vaccination practices aim to establish long-term protection against vaccine-preventable diseases, the durability of this immunity following immunotherapy remains unclear. This study will assess whether pediatric patients (less than 21 years old) who have been treated with blinatumomab retain protective antibody titers from their primary childhood vaccinations and whether revaccination restores immune protection. Because the vast majority of B-ALL patients - including B-Lymphoblastic Lymphoma - will receive 2 cycles of blinatumomab during their treatment, understanding the long-term impact of this drug on vaccine-induced humoral immunity is imperative.
The investigators hypothesize that pediatric patients with B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (B-ALL/Ly) who have received blinatumomab will not retain protective immunity conferred by the routine childhood primary series of vaccinations and that revaccination will result in a robust serologic response.
- Conditions
- B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia, B-Cell Lymphoblastic Leukemia, B-Cell Lymphoblastic Leukemia/Lymphoma, B-cell Acute Lymphoblastic Leukemia (B-ALL), B-cell Acute Lymphoblastic Leukemia
- Keywords
- vaccines, cancer, blinatumomab, immunotherapy
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Leukemia, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants who have received blinatumomab | |
| Controls | Participants who have not received blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with protective serum antibody titers
Participants will have antibody titers evaluated as standard of care. Titers evaluated include: tetanus, Haemophilus influenzae type b [Hib], Hepatitis B, Streptococcus pneumoniae [pneumococcal], Varicella Zoster Virus, and Measles
Measured: >/= 6 months following the completion of blinatumomab therapy
Secondary outcomes (1)
Proportion of participants who achieve seroconversion (i.e., transition from non-protective to protective antibody titers)
Will assess whether revaccination restores protective immunity in participants with non-protective titers after blinatumomab
Measured: within 6 months following revaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start13 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for B-Cell ALLStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Lauren Appell, MD, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422337
- Sponsor's protocol ID
- 299200
- Acronym
- BOOSTER
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers, and each participating site has access to only their center's data; however, aggregated data will be be included in future publications and will be made available to participating centers following study completion.
Publications
Carpenter PA, Englund JA. How I vaccinate blood and marrow transplant recipients. Blood. 2016 Jun 9;127(23):2824-32. doi: 10.1182/blood-2015-12-550475. Epub 2016 Apr 5.
PubMed 27048212Close E, McConnell G, Cross S, Bradford JL. Immunogenicity of Childhood Vaccines after Pediatric Cancer. Am Fam Physician. 2020 Dec 1;102(11):Online. No abstract available.
PubMed 33252910Foundation LR. B-cell Acute Lymphoblastic Leukemia [Internet]. Available from: https://leukemiarf.org/leukemia/acute-lymphoblastic-leukemia/b-cell-lymphoblastic-leukemia
Kyriakidis I, Mantadakis E, Stiakaki E, Groll AH, Tragiannidis A. Infectious Complications of Targeted Therapies in Children with Leukemias and Lymphomas. Cancers (Basel). 2022 Oct 14;14(20):5022. doi: 10.3390/cancers14205022.
PubMed 36291806Toret E, Yel SE, Suman M, Duzenli Kar Y, Ozdemir ZC, Dinleyici M, Bor O. Immunization status and re-immunization of childhood acute lymphoblastic leukemia survivors. Hum Vaccin Immunother. 2021 Apr 3;17(4):1132-1135. doi: 10.1080/21645515.2020.1802975. Epub 2020 Sep 3.
PubMed 32882157Cetin M, Gumy-Pause F, Gualtieri R, Posfay-Barbe KM, Blanchard-Rohner G. Vaccine Immunity in Children After Hematologic Cancer Treatment: A Retrospective Single-center Study. J Pediatr Hematol Oncol. 2024 Jan 1;46(1):e51-e59. doi: 10.1097/MPH.0000000000002774. Epub 2023 Nov 3.
PubMed 37922437Gupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2025 Feb 27;392(9):875-891. doi: 10.1056/NEJMoa2411680. Epub 2024 Dec 7.
PubMed 39651791Wang K, Wei G, Liu D. CD19: a biomarker for B cell development, lymphoma diagnosis and therapy. Exp Hematol Oncol. 2012 Nov 29;1(1):36. doi: 10.1186/2162-3619-1-36.
PubMed 23210908Keskin Yildirim Z, Buyukavci M. Assessment of Humoral Immunity to Hepatitis B, Measles, Rubella, and Mumps in Children After Chemotherapy. J Pediatr Hematol Oncol. 2018 Mar;40(2):e99-e102. doi: 10.1097/MPH.0000000000001072.
PubMed 29309372Lehrnbecher T, Schubert R, Allwinn R, Dogan K, Koehl U, Gruttner HP. Revaccination of children after completion of standard chemotherapy for acute lymphoblastic leukaemia: a pilot study comparing different schedules. Br J Haematol. 2011 Mar;152(6):754-7. doi: 10.1111/j.1365-2141.2010.08522.x. Epub 2011 Jan 20.
PubMed 21250973Anafy A, Gilad G, Michaan N, Elhasid R, Rosenfeld-Kaidar H, Arad-Cohen N, Cohen MS, Shachor-Meyouhas Y, Grisaru-Soen G. Revaccination of children with acute lymphoblastic leukemia following completion of chemotherapy. Pediatr Blood Cancer. 2023 Jun;70(6):e30321. doi: 10.1002/pbc.30321. Epub 2023 Apr 10.
PubMed 37036274
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
- ClinicalTrials.gov ID
- NCT07422337
- Acronym / sponsor ID
- BOOSTER / 299200
- Conditions
- B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia, B-Cell Lymphoblastic Leukemia, B-Cell Lymphoblastic Leukemia/Lymphoma, B-cell Acute Lymphoblastic Leukemia (B-ALL), B-cell Acute Lymphoblastic Leukemia
- Keywords
- vaccines, cancer, blinatumomab, immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Feb 2026 (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.
The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. The main study aims are:
- Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL/Ly who have received blinatumomab.
- To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.
Researchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.
Detailed description
The most common form of malignancy in children is B-cell acute lymphoblastic leukemia (B-ALL). B-ALL is a type of blood cancer resulting from clonal expansion of an abnormal B-cell precursor known as a lymphoblast. Mature normal B-cells are white blood cells produced in the bone marrow that play a crucial role in fighting infections and in humoral immunity. Abnormal, immature B-cells begin to form and multiply quickly, crowding out healthy cells in the bone marrow. As these cancerous B-cells accumulate, they spill into the bloodstream and can spread (metastasize) throughout the body.
CD19 is the antigen expressed on the surface of nearly all B cells throughout all phases of maturation. CD19 expression plays a crucial role in the body's ability to mount an immune response against a pathogen. Through several studies, CD19 was found to be highly conserved among B-cell malignancies, making it an optimal target for B-ALL treatment. Blinatumomab is a bispecific T-cell engager (BiTE) that links the T-cell CD3 and B-cell CD19. This results in the activation, proliferation, and clonal expansion of T-cells resulting in destruction of the targeted CD19+ cells. Blinatumomab has been shown to improve outcomes among pediatric patients diagnosed with B-ALL significantly; and is now a part of the backbone of treatment for B-ALL.
A key concern for the pediatric population receiving blinatumomab is the potential loss of vaccine-induced immunity established before chemotherapy. Intensive chemotherapy in patients with B-cell acute lymphoblastic leukemia (B-ALL) can impair humoral immunity, leading to the loss of antibodies generated by previous vaccinations due to the depletion of memory B cells. Currently, there is no established protocol for revaccination in B-ALL patients treated with blinatumomab. However, prior studies involving other immunotherapeutic agents, such as CAR T-cell therapy, have shown that patients often exhibit low post-treatment antibody titers, necessitating booster doses or even full revaccination. Because blinatumomab has shown to improve outcomes in the vast majority of children with B-ALL, it is critical to determine the unknown long-term effects on humoral immunity in these patients.
Clinical practice regarding revaccination post-chemotherapy in the B-ALL population is widely variable. Children with leukemia who have undergone chemotherapy often experience prolonged immunosuppression, making them particularly vulnerable to vaccine-preventable diseases. The disease itself, combined with its treatment, causes significant immunosuppression-especially in acute lymphoblastic leukemia (ALL)-when compared to solid tumors. While partial immune recovery may occur approximately three months after chemotherapy, full recovery can take longer and depends on factors such as the patient's age, type of cancer, and the intensity of treatment received. In immunocompromised patients, live vaccines are generally considered to be unsafe, putting patients at high risk of viral reactivation. However, non-live (inactivated) vaccines are considered safe and effective. Therefore, it is essential to establish a clear vaccination protocol to protect this vulnerable population from preventable infections.
While standard vaccination practices aim to establish long-term protection against vaccine-preventable diseases, the durability of this immunity following immunotherapy remains unclear. This study will assess whether pediatric patients (less than 21 years old) who have been treated with blinatumomab retain protective antibody titers from their primary childhood vaccinations and whether revaccination restores immune protection. Because the vast majority of B-ALL patients - including B-Lymphoblastic Lymphoma - will receive 2 cycles of blinatumomab during their treatment, understanding the long-term impact of this drug on vaccine-induced humoral immunity is imperative.
The investigators hypothesize that pediatric patients with B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (B-ALL/Ly) who have received blinatumomab will not retain protective immunity conferred by the routine childhood primary series of vaccinations and that revaccination will result in a robust serologic response.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Participants who have received blinatumomab |
| Controls | – | –Participants who have not received blinatumomab |
Who may qualify
- Ages
- 1 year to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Potential participants will be identified through referrals and from medical records. Prospective participants are those who have been captured prior to starting chemotherapy, and retrospective participants are those who have been captured after starting chemotherapy or have finished chemotherapy within the previous 12 months.
Key inclusion criteria (4 listed)
- Diagnosis of B-lineage acute lymphoblastic leukemia/lymphoma
- ≥1 year old and up to 21 years old at diagnosis
- Informed consent provided, and if applicable, child assent provided
- Must have received all vaccinations routinely administered during first year of life
Key exclusion criteria (3 listed)
- Relapsed/refractory disease at any time
- Received or will require a bone marrow transplant and/or cellular therapy
- Pregnancy
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
Proportion of participants with protective serum antibody titers
Time frame: >/= 6 months following the completion of blinatumomab therapy
Participants will have antibody titers evaluated as standard of care. Titers evaluated include: tetanus, Haemophilus influenzae type b [Hib], Hepatitis B, Streptococcus pneumoniae [pneumococcal], Varicella Zoster Virus, and Measles
1 secondary outcome
Proportion of participants who achieve seroconversion (i.e., transition from non-protective to protective antibody titers)
Time frame: within 6 months following revaccination
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 25 Feb 2026.
- Background: PubMed 27048212Carpenter PA, Englund JA. How I vaccinate blood and marrow transplant recipients. Blood. 2016 Jun 9;127(23):2824-32. doi: 10.1182/blood-2015-12-550475. Epub 2016 Apr 5.
- Background: PubMed 33252910Close E, McConnell G, Cross S, Bradford JL. Immunogenicity of Childhood Vaccines after Pediatric Cancer. Am Fam Physician. 2020 Dec 1;102(11):Online. No abstract available.
- BackgroundFoundation LR. B-cell Acute Lymphoblastic Leukemia [Internet]. Available from: https://leukemiarf.org/leukemia/acute-lymphoblastic-leukemia/b-cell-lymphoblastic-leukemia
- Background: PubMed 36291806Kyriakidis I, Mantadakis E, Stiakaki E, Groll AH, Tragiannidis A. Infectious Complications of Targeted Therapies in Children with Leukemias and Lymphomas. Cancers (Basel). 2022 Oct 14;14(20):5022. doi: 10.3390/cancers14205022.
- Background: PubMed 32882157Toret E, Yel SE, Suman M, Duzenli Kar Y, Ozdemir ZC, Dinleyici M, Bor O. Immunization status and re-immunization of childhood acute lymphoblastic leukemia survivors. Hum Vaccin Immunother. 2021 Apr 3;17(4):1132-1135. doi: 10.1080/21645515.2020.1802975. Epub 2020 Sep 3.
- Background: PubMed 37922437Cetin M, Gumy-Pause F, Gualtieri R, Posfay-Barbe KM, Blanchard-Rohner G. Vaccine Immunity in Children After Hematologic Cancer Treatment: A Retrospective Single-center Study. J Pediatr Hematol Oncol. 2024 Jan 1;46(1):e51-e59. doi: 10.1097/MPH.0000000000002774. Epub 2023 Nov 3.
- Background: PubMed 39651791Gupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2025 Feb 27;392(9):875-891. doi: 10.1056/NEJMoa2411680. Epub 2024 Dec 7.
- Background: PubMed 23210908Wang K, Wei G, Liu D. CD19: a biomarker for B cell development, lymphoma diagnosis and therapy. Exp Hematol Oncol. 2012 Nov 29;1(1):36. doi: 10.1186/2162-3619-1-36.
- Background: PubMed 29309372Keskin Yildirim Z, Buyukavci M. Assessment of Humoral Immunity to Hepatitis B, Measles, Rubella, and Mumps in Children After Chemotherapy. J Pediatr Hematol Oncol. 2018 Mar;40(2):e99-e102. doi: 10.1097/MPH.0000000000001072.
- Background: PubMed 21250973Lehrnbecher T, Schubert R, Allwinn R, Dogan K, Koehl U, Gruttner HP. Revaccination of children after completion of standard chemotherapy for acute lymphoblastic leukaemia: a pilot study comparing different schedules. Br J Haematol. 2011 Mar;152(6):754-7. doi: 10.1111/j.1365-2141.2010.08522.x. Epub 2011 Jan 20.
- Background: PubMed 37036274Anafy A, Gilad G, Michaan N, Elhasid R, Rosenfeld-Kaidar H, Arad-Cohen N, Cohen MS, Shachor-Meyouhas Y, Grisaru-Soen G. Revaccination of children with acute lymphoblastic leukemia following completion of chemotherapy. Pediatr Blood Cancer. 2023 Jun;70(6):e30321. doi: 10.1002/pbc.30321. Epub 2023 Apr 10.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers, and each participating site has access to only their center's data; however, aggregated data will be be included in future publications and will be made available to participating centers following study completion.
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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.
Stephanie Thomas, RN contact
Lauren Appell, MD principal investigator
Arkansas Children's Research Institute
2 sites 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 ALL and B-Cell Acute Lymphoblastic Leukaemia, run by Arkansas Children's Hospital Research Institute at 2 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 4 inclusion and 3 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Lauren Appell, MD (501-364-1494, leappell@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with protective serum antibody titers (time frame: >/= 6 months following the completion of blinatumomab therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422337, which also lists 11 linked publications.
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 25 Feb 2026.