Blinatumomab with Dasatinib or Imatinib for B-ALL

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)

Recruiting Phase 2 Interventional Study
B Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
366 Days – 46
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
222 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for children, adolescents, and young adults diagnosed with a specific type of leukemia called B-cell Acute Lymphoblastic Leukemia (B-ALL). Participants will receive a new combination treatment that includes a drug called blinatumomab along with either dasatinib or imatinib and standard chemotherapy.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 1 and 45 years old.
  • I have been diagnosed with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-ALL.
  • I have started induction therapy for my leukemia.
  • I have specific gene expressions related to my leukemia.
  • I have a performance status of 2 or lower.
  • I have certain kidney function levels.
  • I have normal liver function tests.
  • I have a good heart function as measured by echocardiogram.

You may not be able to join if

  • I have a history of chronic myeloid leukemia (CML).
  • I have severe central nervous system issues.
  • I am pregnant or breastfeeding.
  • I have an active infection that requires hospitalization.
  • I have Down syndrome.
  • I have a history of significant heart problems.
  • I have had previous cancers treated with chemotherapy.
  • I have a history of uncontrolled seizures.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 an…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must be \> 365 days and \< 18 years (for AIEOP-BFM), \> 365 days and \< 22 years (for Children's Oncology Group \[COG\]) 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…
Contacts

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