Gives early leukemia treatment while tumor testing determines risk group in children
Tests early treatment for newly diagnosed leukemia or lymphoma in children and young people.
Key facts
- Who runs it
- St. Jude Children's Research Hospital
- Where
- Baton Rouge, Charlotte, Memphis, San Diego, and Tulsa, United StatesSee the 5 sites
- Trial code
- Registry title
- Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 850 people, planned
- Started
- 26 Dec 2024
- Expected to end
- May 2039
- Type of study
- Interventional
- Treatments tested
- Dexamethasone
- Vincristine
- Daunorubicin
- Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
- Methotrexate
- Cytarabine
- Record updated
- 14 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people with newly diagnosed acute lymphoblastic leukemia, lymphoblastic lymphoma or mixed phenotype acute leukemia. It gives treatment while the risk category is being determined.
- Age
- Age 1-18.99 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or clear signs of ALL in the blood; lymphoblastic lymphoma (LLy) with <25% bone marrow blasts and less than 1,000 circulating blasts/ microL; or mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement.
- Earlier treatment
- People cannot have had cancer treatment before, except up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy for a mass harming an organ. Earlier steroid treatment is allowed.
Main reasons for not taking part
- Pregnant or breastfeeding
- Earlier cancer treatment beyond the allowed exceptions
- Known to be currently ineligible for available SJALL therapeutic studies
- Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth
- Participant or legal guardian unable or unwilling to give written informed consent
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Age 1-18.99 years
- Diagnosis of acute leukemia / lymphoma as below:; Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample); Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and <25% bone marrow blasts and less than 1,000 circulating blasts/ microL; Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible)
Who cannot take part
- Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.); Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL
- Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy
- Pregnant or breastfeeding
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
- Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Where in United States
- Our Lady of the Lakes Regional Medical CenterBaton Rouge, United StatesContact: Sakshi Bami, MDTaking people
- Novant Health Presbyterian Hemby Children's HospitalCharlotte, United StatesContact: Jessica Bell, MDTaking people
- St. Jude Children's Research HospitalMemphis, United StatesContact: Seth E. Karol, MDTaking people
- Rady Children's HospitalSan Diego, United StatesContact: Victor Wong, MDTaking people
- Saint Francis Children's HospitalTulsa, United StatesContact: Ashraf Mohamed, MDTaking people
About the trial
What the trial wants to find out
The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
Read full original descriptionShow less
Primary Objectives
* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies. * To develop a central database of genomic and clinical findings.
Secondary Objectives
* To assess event free and overall survival data of patients enrolled on this study.
The group in the trial
- Newly diagnosed ALL, LLy, and MPAL patientsTreatment being tested
All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Treatment: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine), Methotrexate, and Cytarabine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
- Plain-language title
- Gives early leukemia treatment while tumor testing determines risk group in childrenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06289673, who can take part
- Record updated
- 14 July 2026