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

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06289673
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
  • Vincristine — DRUG
    Intravenously (IV) for 1 dose on Day 1 or 2
  • Daunorubicin — DRUG
    Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
  • Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) — DRUG
    Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
  • Methotrexate — DRUG
    Given IT as part of Intrathecal triple therapy.
  • Cytarabine — DRUG
    Given IT as part of Intrathecal triple therapy.

Study Details

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.

Key Dates

Start date
Dec 26, 2024
Status verified
Apr 2026
Primary completion
May 31, 2034
Completion
May 31, 2039

Study Design

Enrollment
850 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rady Children's HospitalSan DiegoCalifornia92123
Victor Wong, MD
[email protected]
858-966-5811
Victor Wong, MD (PRINCIPAL_INVESTIGATOR)
Saint Francis Children's HospitalTulsaOklahoma74136
Ashraf Mohamed, MD
[email protected]
918-502-6720
Ashraf Mohamed, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Seth E. Karol, MD
[email protected]
888-226-4343
Seth E. Karol, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Rady Children's Hospital· San Diego, CASaint Francis Children's Hospital· Tulsa, OKSt. Jude Children's Research Hospital· Memphis, TN

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