Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and 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
- Time periods mentioned: 10 years
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
- "Follow-up is recommended until the patient is in remission for 10 years and is at least 18 years old."
- 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 phase 2 study tests inotuzumab and blinatumomab as part of the first treatment for newly diagnosed B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. These drugs target cancer cells. The study is for children and young adults ages 1 through 18 who meet certain risk and health requirements.
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be enrolled in INITIALL and be age 1 through 18 when joining it.
- Have B-cell ALL, a blood cancer, or lymphoblastic lymphoma, a cancer of cells that normally fight infection.
- Have had no chemotherapy except treatment given or allowed by INITIALL.
- For ALL, have high-risk disease: age 10 or older, a white blood cell count of at least 50,000, or certain other risk signs. These include cancer in the brain or spinal fluid or testicles, or certain steroid use before joining.
- For lymphoma, have stage 3 or 4 disease, stage 1 or 2 disease at age 10 or older, or one of the other risk signs listed above.
- Have liver and kidney test results within the study’s allowed limits.
- To join after the first treatment phase, meet the study’s special rules. These allow patients treated on SJALL23H, certain lymphoma patients whose cancer has not fully cleared, or certain ALL patients with a slow response or high-risk gene changes.
- ALL patients switching because of a slow response or high-risk gene changes may have no more than 2 weeks of treatment after the first phase. They should switch as soon as the qualifying test result is ready.
Who can't join
- Have the ETV6::RUNX1 gene change, unless there is also a high-risk clinical sign or a slow response to the first treatment phase.
- Have a serious brain or nervous system condition, such as epilepsy, stroke, or severe brain injury. Simple childhood seizures caused by fever and ALL in the brain or spinal fluid at diagnosis do not rule you out.
- Have an active infection that is not controlled.
- Have an active autoimmune disease, where the immune system attacks the body, or a past autoimmune disease that could affect the brain or spinal cord.
- Have had blocked small blood vessels in the liver, called veno-occlusive disease or sinusoidal obstruction syndrome.
- Have unstable heart disease, including a QTc above 500 milliseconds on a heart rhythm test.
- Be unable or unwilling to give the required permission to take part.
- Be pregnant or breastfeeding, or be able to have children but unwilling to use effective birth control throughout study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Enrollment on INITIALL. * Age 1-18.99 years at the time of enrollment on INITIALL. * B-Acute lymphoblastic leukemia or lymphoblastic lymphoma. * No prior chemotherapy excluding therapy given on or allowed by INITIALL. * NCI high-risk (age 10 years or greater or presenting WBC count ≥50,000 cells/microL) or NCI standard-risk and a HR clinical feature as listed below: * CNS3 disease (≥5 WBC/microL CSF with blasts present) * Testicular involvement of leukemia * Steroid pretreatment defined as \>24 hours of therapy in the 14 days prior to enrollment on INITIALL if a preceding WBC to define NCI risk is unavailable * For lymphoblastic lymphoma, Stage 3-4 disease OR Stage 1-2 disease in patient ages ≥10 years OR HR clinical feature as defined above. * Adequate liver function defined as: * Total bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. Patients with an elevated total bilirubin due to hemolysis are eligible if they have a direct bilirubin \<1.5x the upper limit of normal. * Adequate renal function defined as: * Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below: * Age: 1 to \<2 years; maximum serum creatinine (mg/dL): 0.6 (male and female) * Age: 2 to \<6 years; maximum serum creatinine (mg/dL): 0.8 (male and female) * Age: 6 to \<10 years; maximum serum creatinine (mg/dL): 1.0 (male and female) * Age: 10 to \<13 years; maximum serum creatinine (mg/dL): 1.2 (male and female) * Age: 13 to \<16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age: ≥16 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) * Eligibility for inclusion post-induction requires meeting the first 4 Inclusion criteria above AND: * Treatment on SJALL23H for Induction OR * Lymphoblastic lymphoma, initially treated on an SJALL protocol OR standard (non-protocol) therapy, without a complete response at the end of induction OR * NCI-SR ALL at diagnosis and treated with an SJALL protocol OR standard (non-protocol) therapy who have * Slow response to therapy (≥0.1% MRD at end of induction for patients with hyperdiploid ALL or ≥0.01% MRD at end of induction for others with ALL) OR * HR genetics as defined in the protocol. * These patients may receive no more than 2 weeks of post-induction therapy and should be transitioned to SJALL23H post-induction as soon as the qualifying genetic or MRD result is available. Exclusion Criteria: * Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy. * History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation. * Active uncontrolled infection. * Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement. * History of venoocclusive disease/ sinusoidal obstructive syndrome. * Unstable cardiac disease including QTc \>500msec. * Inability or unwillingness to give informed consent/ assent as applicable. * Pregnant or lactating. * For patients of reproductive potential, unwillingness to use effective contraception for the duration of protocol therapy.
Study sites (3)
NC
- Novant Health Presbyterian Hemby Children's Hospital · Charlotte, NC 28204Jessica Bell, MD · Study contact · 704-384-1900 · jbell@novanthealth.orgJessica Bell, MD · Principal investigatorMore trials in Charlotte
OK
- Saint Francis Children's Hospital · Tulsa, OK 74136Ashraf Mohamed, MD · Study contact · 918-502-6720 · ammohamed@saintfrancis.comAshraf Mohamed, MD · Principal investigatorMore trials in Tulsa
TN
- St. Jude Children's Research Hospital · Memphis, TN 38105Seth E. Karol, MD, MSCI · Study contact · 888-226-4343 · referralinfo@stjude.orgSeth E. Karol, MD, MSCI · Principal investigatorMore trials in Memphis