Study on Essential Information for Starting Treatment in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT06289673

Provider View

This study aims to ensure that patients with newly diagnosed B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) receive the right amount of treatment while their risk category is being determined. The risk category helps predict the chance of the cancer returning after treatment.

Patient Parameters

Program Overview

The purpose of this study is to provide the necessary treatment for patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) while their risk level is being assessed. This helps determine the best treatment plan for them. The study also aims to create a central database of genetic and clinical information. Additionally, it will track the survival rates and outcomes of patients involved in the study.

Description

Patients who have just been diagnosed with acute lymphoblastic leukemia/lymphoma (ALL/LLy) or mixed phenotype acute leukemia/lymphoma (MPAL) will undergo tests either during the screening process or on the first day of the study. They will receive a 7-day course of chemotherapy, which includes 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for those with T-ALL/LLy or MPAL only). During this time, patients will also have their first lumbar puncture with chemotherapy injected into the spinal fluid on Days 4, 5, or 6. After completing the 7 days of chemotherapy, patients will either start treatment on a specific SJALL therapeutic trial or receive other standard treatments.

Eligibility Criteria

Inclusion Criteria

  • Age between 1 and 18.99 years old.
  • Diagnosed with one of the following types of leukemia/lymphoma:
    • Acute lymphoblastic leukemia (ALL) with at least 25% cancer cells in the bone marrow or clear evidence of ALL in the blood if a bone marrow sample is not available.
    • Lymphoblastic lymphoma (LLy) with specific markers showing a lymphoblastic population and less than 25% cancer cells in the bone marrow and fewer than 1,000 cancer cells per microliter in the blood.
    • Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (patients with either leukemia or lymphoma are eligible).

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Have received prior cancer treatment, except for up to 1 dose of chemotherapy injected into the spinal fluid, 1 dose of vincristine, or emergency radiation due to a life-threatening tumor. Previous steroid treatment is allowed.
  • Known to be currently ineligible for available SJALL therapeutic studies (e.g., have received prohibited therapy, no suitable SJALL study available, enrolled in another trial).
  • Unable or unwilling to provide written consent from the patient or their legal guardian.
  • Have major pre-existing conditions such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.

Locations

FACILITYZIPCITYSTATE
United States, Tennessee St. Jude Children's Research Hospital38105MemphisTennessee

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