Acute Lymphoblastic LeukemiaNCT07246213
CAYA Cancer Retrospective Cohort Study
An observational study of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Resonance, Inc. at 7 sites in 6 countries.
Trial summary
Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment… Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Young Adult Cancer
- What is being tested?
- Retrospective Medical Record Review
- How many people
- 18,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 4 Jun 2025to 4 Dec 2028
- Phase
- Observational
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 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will comprise pediatric patients aged 0-21 years diagnosed with cancer, reflecting diverse demographic backgrounds and clinical characteristics.
Who may be able to join
- Subjects must meet all the following criteria to be included in this registry:
- Participants must be willing and able to provide informed consent prior to enrollment in the registry.
- For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
- Note: Exemption applies to this criterion when waiver of informed consent/assent is granted by Institutional Review Board(IRB)/Independent Ethics Committee(IEC)/Competent Authorities(CAs).
- A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
- Age 0 to 21 years at the time of diagnosis.
Show all 12Show fewer
- Received substantial anti-cancer treatment at the participating center, including but not limited to:
- Chemotherapy
- Surgery
- Radiation therapy
- Immunotherapy
- Medical records are available and accessible for review
Who cannot join
- Subjects meeting any of the following criteria will be excluded from this registry:
- Patients who only visited the participating center for:
- Consultation without subsequent primary anti-cancer treatment at the participating center
- Pathology, radiology, or other diagnostic evaluations without treatment
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Honduras2 sites, 2 recruiting
- Recruiting
Hospital Mario Catarino Rivas
San Pedro Sula, Cortés Department, 21102
Roxana Martinez, MD., roxmartinez@doctor.com
- Recruiting
Hospital Escuela
Tegucigalpa, Distrito Central, 11101
Ligia Fu, MD., ligiafucarrasco@yahoo.com
Armenia1 site, 1 recruiting
- Recruiting
Yeolyan Center for Cancer and Blood Disorders
Yerevan
Anna Avagyan, MD, +010283800, avagyananna2010@gmail.com
Egypt1 site, 1 recruiting
- Not yet recruiting
The Children's Cancer Hospital Egypt 57357
Cairo
Iman Sidhom, MD, +202 25351500, iman.sidhom@57357.org
Alaa El Haddad, MD, Alaa.Hadad@57357.org
El Salvador1 site, 1 recruiting
- Recruiting
Fundación Ayúdame a Vivir
El Salvador, El Salvador, 1101
Roberto Vasquez, MD., rfranklinvz@gmail.com
Guatemala1 site, 1 recruiting
- Recruiting
Unidad Nacional de Oncología Pediátrica (UNOP)
Guatemala City
Jeanine Alfaro, MD, 50223177800 ext. 502, jalfaroflowcyt@ayuvi.org.gt
Tanzania1 site, 1 recruiting
- Not yet recruiting
Kilimanjaro Christian Medical Center
Moshi
Esther Maialiwa, MD, +255 755 001 312, mainda.emo@gmail.com
About this study
Official title: Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries
Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.
Acute lymphoblastic leukemia(ALL)/lymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.
This study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia/lymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Young Adult Cancer, Adolescent Cancer, Childhood Cancers, Acute Lymphoblastic Leukemia (ALL)
- Being tested
- Retrospective Medical Record Review
- Keywords
- Cancer outcomes, Low- and Middle-Income Countries (LMICs), Childhood cancer, Adolescent and young adult cancer (CAYA), Treatment failure, Therapy-related toxicities, Retrospective cohort, Leukemia outcomes, Oncology disparities, High-Income Countries (HICs)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Medical Record ReviewOther
This study involves retrospective review of medical records of pediatric, adolescent, and young adult cancer patients (ages 0-21 years) treated at participating oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. No experimental drug, device, or behavioral intervention is being administered. Data abstraction will be performed to assess treatment failure, therapy-related toxicities, and clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| All Cancer Diagnoses | Patients aged 0-21 years with any type of cancer diagnosis. Retrospective medical record review will capture incidence of treatment failure, including relapse, progression, or abandonment. Receives: Other: Retrospective Medical Record Review | |
| Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma | Patients aged 0-21 years diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. Retrospective review will focus on therapy-related toxicities and treatment outcomes in this subgroup. Receives: Other: Retrospective Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the incidence of treatment failure, in patients with any type of cancer diagnosis.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To estimate the incidence of Grade 3, 4, and 5 therapy-related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
Secondary outcomes (4)
To estimate the incidence of treatment failure by cancer type, treatment regimen, age groups, and sociodemographic variables of patients diagnosed with any cancer.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of cancer.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To estimate the event-free survival (EFS) and overall survival (OS) for patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
To describe patterns of relapse in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Measured: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Jun 2025
- Primary completion4 Jun 2028 (estimated)
- Study completion4 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resonance, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Servier Affaires Médicales
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246213
- Sponsor's protocol ID
- RES-NIT-101-25
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the plan for sharing individual participant data (IPD) remains undecided. As the study continues to expand to new sites and additional countries, a comprehensive assessment of applicable data protection and privacy regulations in each jurisdiction is required. A final determination regarding IPD sharing will be made once compliance with all relevant national and international legal frameworks has been ensured.
Publications
Rodriguez-Galindo C, Friedrich P, Alcasabas P, Antillon F, Banavali S, Castillo L, Israels T, Jeha S, Harif M, Sullivan MJ, Quah TC, Patte C, Pui CH, Barr R, Gross T. Toward the Cure of All Children With Cancer Through Collaborative Efforts: Pediatric Oncology As a Global Challenge. J Clin Oncol. 2015 Sep 20;33(27):3065-73. doi: 10.1200/JCO.2014.60.6376. Epub 2015 Aug 24.
PubMed 26304881Pui CH, Yang JJ, Bhakta N, Rodriguez-Galindo C. Global efforts toward the cure of childhood acute lymphoblastic leukaemia. Lancet Child Adolesc Health. 2018 Jun;2(6):440-454. doi: 10.1016/S2352-4642(18)30066-X. Epub 2018 Mar 30.
PubMed 30169285Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.
PubMed 28819280Chantada G, Lam CG, Howard SC. Optimizing outcomes for children with non-Hodgkin lymphoma in low- and middle-income countries by early correct diagnosis, reducing toxic death and preventing abandonment. Br J Haematol. 2019 Jun;185(6):1125-1135. doi: 10.1111/bjh.15785. Epub 2019 Feb 10.
PubMed 30740656Howard SC, Zaidi A, Cao X, Weil O, Bey P, Patte C, Samudio A, Haddad L, Lam CG, Moreira C, Pereira A, Harif M, Hessissen L, Choudhury S, Fu L, Caniza MA, Lecciones J, Traore F, Ribeiro RC, Gagnepain-Lacheteau A. The My Child Matters programme: effect of public-private partnerships on paediatric cancer care in low-income and middle-income countries. Lancet Oncol. 2018 May;19(5):e252-e266. doi: 10.1016/S1470-2045(18)30123-2.
PubMed 29726390