Combination Chemotherapy for Young Patients with High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02883049

Provider View

This study is testing how well a combination of chemotherapy drugs works for young patients with a specific type of leukemia that is likely to return or spread. It also looks at patients with a certain genetic mutation that may respond to targeted therapy.

Patient Parameters

Program Overview

This clinical trial is exploring the effectiveness of using multiple chemotherapy drugs together to treat young patients who have been newly diagnosed with high-risk B acute lymphoblastic leukemia (ALL). The study also includes patients with a specific genetic mutation that may respond to targeted therapy. The goal is to see if this approach can better stop the cancer from growing, spreading, or coming back.

Description

The main goal of this study is to find out if a specific combination of chemotherapy drugs can improve the chances of staying cancer-free for five years in children with high-risk B acute lymphoblastic leukemia (ALL). The study also aims to see if adding certain drugs can help children, teenagers, and young adults with very high-risk B-ALL live longer without the cancer returning.

The study will also look at how safe and tolerable these treatments are for patients, including those with Down syndrome. Researchers will also study the effects of the treatment on the brain and cognitive functions in children.

Participants will receive different phases of treatment, including induction therapy, consolidation therapy, interim maintenance therapy, delayed intensification therapy, and maintenance therapy. Each phase involves different combinations of chemotherapy drugs given over specific periods.

The study will also explore the outcomes for patients with a specific genetic mutation that may respond to targeted therapy, using a drug called dasatinib.

After completing the study treatment, patients will be followed up periodically for 10 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in a related screening study before joining this trial.
  • Must have a newly diagnosed type of leukemia called B acute lymphoblastic leukemia (B-ALL).
  • Must meet specific white blood cell count criteria based on age.
  • Patients with Down syndrome are eligible.
  • Must have good organ function and meet specific blood test criteria.
  • Must not have major heart problems and have good heart function.
  • Must not have breathing problems at rest.
  • Patients with controlled seizure disorders may participate.
  • Must be between 6 and 13 years old for the neurocognitive study.
  • Must speak English, French, or Spanish.
  • Must not have a history of certain developmental disorders.
  • Must not have significant visual impairments.
  • Must meet specific criteria if previously enrolled in a related study.
  • Must sign a written informed consent form.

Exclusion Criteria

  • Must not have received prior chemotherapy for the current leukemia diagnosis.
  • Must not have a specific genetic fusion called BCR-ABL1 for post-induction therapy.
  • Female patients who are pregnant or breastfeeding are not eligible.
  • Female patients of childbearing potential must have a negative pregnancy test.
  • Sexually active patients must agree to use effective contraception during the study.

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