Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06289673

Conditions

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Vincristine

Daunorubicin

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Methotrexate

Study Details

Brief summary:

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.

Conditions

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Mixed Phenotype Acute Leukemia

Study ID

NCT06289673

Start date

Dec 26, 2024

Status verified date

Jul, 2026

Completion date

May, 2039

Anticipated

Primary completion date

May, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Pregnant or breastfeeding
  • 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.
  • 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.

  • 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.

Study Design

Enrollment

850 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Newly diagnosed ALL, LLy, and MPAL patients

All eligible patients receive the following intervention:

Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Interventions

Dexamethasone

Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7

Vincristine

Intravenously (IV) for 1 dose on Day 1 or 2

Daunorubicin

Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6

Methotrexate

Given IT as part of Intrathecal triple therapy.

Cytarabine

Given IT as part of Intrathecal triple therapy.

Primary outcome measure

  • Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). [ Time Frame: 1 week from study entry ]
  • Complete data within the INITIALL database [ Time Frame: 3 months, 1 year, 3, 5 years from study entry ]

Central Contacts and Locations

Central contacts

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

Victor Wong, MD

Our Lady of the Lakes Regional Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Principal Investigator:

Sakshi Bami, MD

Novant Health Presbyterian Hemby Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Jessica Bell, MD

Saint Francis Children's Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Principal Investigator:

Ashraf Mohamed, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Principal Investigator:

Seth E. Karol, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Newly Diagnosed
  • Risk Category
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Mixed Phenotype Acute Leukemia (MPAL)
  • Children
  • Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-14.