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

St. Jude Children's Research Hospital

Status and phase

Enrolling

Phase 4

Conditions

Mixed Phenotype Acute Leukemia

Lymphoblastic Lymphoma

Acute Lymphoblastic Leukemia

Treatments

Drug: Dexamethasone

Drug: Daunorubicin

Drug: Methotrexate

Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Drug: Cytarabine

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT06289673

NCI-2024-01659 (Registry Identifier)

INITIALL

Details and patient eligibility

About

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.

Full 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.

Enrollment

850 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

850 participants in 1 patient group

Newly diagnosed ALL, LLy, and MPAL patients

Experimental group

Description: