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New treatment option for B Acute Lymphoblastic Leukemia
Official title A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
ClinicalTrials.gov ID: NCT06124157
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for b acute lymphoblastic leukemia.
Also referred to as AMG 103, AMG-103.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 366 to 46
You may be able to join if
- Patients must be \> 365 days and \ 365 days and \ 365 days and \< 46 years (for ALLTogether sites) at the time of enrollment
- Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the...
- Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during...
- Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase...
- Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
You likely can't join if
- Known history of chronic myeloid leukemia (CML)
- ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- Down syndrome (trisomy 21)
- Pregnancy and breast feeding
See the full eligibility criteria
- Patients must be \> 365 days and \ 365 days and \ 365 days and \< 46 years (for ALLTogether sites) at the time of enrollment
- Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib...
- Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should...
- Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic...
- Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
- Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
- Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky...
- For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise...
- Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
- Measured GFR ≥ 50 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule...
- For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to...
- Direct bilirubin \< 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- \ Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) OR
- Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) AND
- Corrected QT Interval, QTc \< 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary])
- Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment
- Known history of chronic myeloid leukemia (CML)
- ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- Down syndrome (trisomy 21)
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within...
- Lactating females who plan to breastfeed their infants
- Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol
- NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib...
- Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
- Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
- Patients with known Charcot-Marie-Tooth disease
- Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS)...
- Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not...
- HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Downey, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
+ 115 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 366 days to 46 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Downey, California, United States; Loma Linda, California, United States and 129 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.