Identifying treatment needs for newly diagnosed acute leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to provide timely therapy for patients with newly diagnosed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LLy), or mixed phenotype acute leukemia (MPAL) while determining their risk category for recurrence. Patients will receive a 7-day chemotherapy regimen that includes dexamethasone, vincristine, and daunorubicin, along with initial lumbar puncture for intrathecal chemotherapy. The study also seeks to create a central database of genomic and clinical findings to enhance risk stratification for future therapeutic studies. Additionally, it will assess event-free and overall survival data for enrolled patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rady Children's Hospital
  San Diego, California, United States Recruiting
• Our Lady of the Lakes Regional Medical Center
  Baton Rouge, Louisiana, United States Recruiting
• Novant Health Presbyterian Hemby Children's Hospital
  Charlotte, North Carolina, United States Recruiting
• Saint Francis Children's Hospital
  Tulsa, Oklahoma, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Seth E. Karol, MD — St. Jude Children's Research Hospital
• Study coordinator: Seth E. Karol, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.