NCT06289673

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.

Conditions

• Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma
• Mixed Phenotype Acute Leukemia

Interventions

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

Timeline

• Start date: 2024-12-26
• Primary completion: 2034-05-01
• Completion: 2039-05-01
• First posted: 2024-03-04
• Last updated: 2026-03-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study