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RecruitingPhase 4

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study provides treatment for children and teens with newly diagnosed acute leukemia or lymphoblastic lymphoma while their cancer samples are tested. The tests help show the chance of the cancer coming back and which SJALL treatment study may fit. The study also collects genetic and health information and tracks survival.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 1 through 18 years.
  • Have one of these diagnoses: acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LLy), or mixed phenotype acute leukemia (MPAL).
  • For ALL: at least 25% of bone marrow cells are blasts (immature blood cells), or clear proof of ALL in the blood if no bone marrow sample is available.
  • For LLy: cell tests confirm the diagnosis, with less than 25% blasts in bone marrow and fewer than 1,000 blasts per microliter of blood.
  • For MPAL: a cancer with features of more than one blood cell type. Patients with leukemia or lymphoma may join, regardless of the amount of cancer in the bone marrow.

Who can't join

  • Pregnant or breastfeeding.
  • Past cancer treatment, except up to one chemotherapy dose into spinal fluid, one vincristine dose, or emergency radiation for a cancer mass threatening an organ. Past steroid treatment is allowed.
  • Already known to be unable to join an available SJALL treatment study—for example, because of past treatment or being in a competing study. Being found unable to join later, based on this study's tests, does not rule you out of this study.
  • The patient or their legal guardian or representative cannot or will not give written consent to join.
  • A major health condition already present, such as ataxia telangiectasia, Fanconi anemia, or Charcot-Marie-Tooth disease.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (5)

CA

LA

NC

OK

TN