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NCT06289673RecruitingPhase 4

Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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. 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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
850 (estimated)
First submitted
23 Feb 2024
Start date
26 Dec 2024
Primary completion date
31 May 2034
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT06289673

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 850
  • From 26 Dec 2024 to the primary completion date, 31 May 2034
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Our Lady of the Lakes Regional Medical Center
Coordinator of this site? Confirm its status
Baton RougeUnited StatesRecruiting
Novant Health Presbyterian Hemby Children's Hospital
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Rady Children's Hospital
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
Saint Francis Children's Hospital
Coordinator of this site? Confirm its status
TulsaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.