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Anti-tumor antibiotic

Chemotherapy for Acute Lymphoblastic Leukemia

Phase 3

Waitlist Available

Led By Michael J Burke

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

White Blood Cell Count (WBC) Criteria: Age 1-9.99 years: WBC >= 50 000/uL, Age 10-30.99 years: Any WBC, Age 1-30.99 years: Any WBC with Testicular leukemia, CNS leukemia (CNS3), Steroid pretreatment, Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible, Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131, Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73 m^2 or a serum creatinine based on age/gender, Direct bilirubin =< 3 x upper limit of normal (ULN) for age, Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x upper limit of normal (ULN) for age, Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated radionuclide study, Patients must have an electrocardiogram (EKG) fewer than 6 days prior to enrollment on the dasatinib arm; patients who have had cardiac assessments by echocardiogram or radionuclide scan at the beginning of induction do not need to have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on baseline electrocardiogram as measured by the Friderica or Bazett formula, No major conduction abnormality (unless a cardiac pacemaker is present), No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at sea level if there is clinical indication for determination, Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital) should be avoided, Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study: Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on AALL1131, Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available), Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental retardation), Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli, Eligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of Induction: Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR B-ALL stratum of this study at the end of Induction, Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum of AALL1131, Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR B-ALL stratum of this study at the end of Induction, All patients and/or their parents or legal guardians must sign a written informed consent, All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study combination chemotherapy in young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations.

Who is the study for?

This trial is for young patients with high-risk B acute lymphoblastic leukemia and specific mutations that make them sensitive to certain drugs. They must meet organ function requirements, have no major heart conduction issues, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have received prior cytotoxic chemotherapy.

What is being tested?

The study tests how well a combination of chemotherapy drugs works against aggressive B acute lymphoblastic leukemia in children and young adults. It includes various medications like Dasatinib and Dexamethasone among others, given in different doses and combinations to see which is most effective at killing cancer cells.

What are the potential side effects?

Potential side effects from the treatments may include damage to organs due to drug toxicity, increased risk of infections, allergic reactions, nausea or vomiting from chemotherapy agents. Specific side effects will vary based on the particular combination of drugs administered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone

DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)

Secondary study objectives

5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM

DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM

Incidence of Osteonecrosis (ON) Defined by Magnetic Resonance (MR) Imaging in Children, Adolescents, and Young Adults 10 Years of Age and Greater

+11 more

Other study objectives

The Reduction in MRD From End-Induction (EOI) to End-Consolidation (EOC) for Children, Adolescents, and Young Adults With VHR B-ALL Receiving Experimental Arms 1 Compared to the Control Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Group III PH-like predicted TKI-sensitive kinase mutationExperimental Treatment13 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group II: Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014)Experimental Treatment15 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group III: Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)Experimental Treatment13 Interventions

Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group IV: Group I Arm B (HR B-ALL) (CLOSED 03/19/2018)Experimental Treatment15 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group V: Group I Arm A (HR B-ALL)Experimental Treatment14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Group VI: DS HR B-ALL (SER)Experimental Treatment14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group VII: DS HR B-ALL (RER)Experimental Treatment13 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.

Group VIII: Group II Arm A (VHR B-ALL - Control Arm)Active Control14 Interventions

Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Leucovorin Calcium

2011