Identifying treatment needs for newly diagnosed acute leukemia and lymphoma
INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
This study is testing a new 7-day chemotherapy treatment for people newly diagnosed with acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia to see how well it works and to better understand their risk of recurrence.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Trial ID | NCT06289673 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 18.99 years who have been newly diagnosed with acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia.
Not a fit: Patients who are pregnant, breastfeeding, or have received prior cancer-directed therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for children with acute leukemia and lymphoma.
How similar studies have performed: Other studies have shown success in similar approaches to risk stratification and treatment induction in pediatric leukemia and lymphoma.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California and 2 other locations
- Rady Children's Hospital — San Diego, California, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.