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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to improve treatment for children and young adults diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy). The main goal is to ensure that patients receive the right therapy while doctors figure out the risk level of their cancer, which helps determine how likely it is to come back after treatment. By collecting and analyzing tumor samples, the study aims to categorize patients correctly and contribute to a larger database of clinical and genetic information that could help future treatments.

To be eligible for this trial, participants should be between 1 and 18 years old and have a confirmed diagnosis of specific types of acute leukemia or lymphoma. There are some restrictions, like not being pregnant or having received certain previous treatments. If you or a family member join the trial, you can expect to receive careful monitoring and therapy while your cancer risk is assessed, and this information could help improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• 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.