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

ClinicalTrials ID:NCT02883049

Provider View

This study is testing how well a combination of chemotherapy drugs works for young patients with newly diagnosed high-risk B acute lymphoblastic leukemia (ALL) that is likely to return or spread, and for those with specific genetic mutations sensitive to certain targeted treatments.

Patient Parameters

Program Overview

This clinical trial is exploring the effectiveness of using multiple chemotherapy drugs together to treat young patients with a type of blood cancer called B acute lymphoblastic leukemia (ALL). The study focuses on patients whose cancer is considered high-risk, meaning it might come back or spread, and those with specific genetic changes that respond to targeted treatments. The goal is to see if this combination approach can stop the cancer cells from growing, dividing, or spreading.

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 looks at whether adding certain drugs can help young patients with very high-risk ALL.

Researchers are also interested in understanding the side effects and how well patients tolerate these treatments. They are exploring if a modified treatment plan can help children with Down syndrome who have high-risk ALL. Additionally, the study examines the outcomes for patients with a specific genetic mutation that makes them sensitive to targeted treatments.

The study involves several phases of treatment, including induction therapy to start the process, consolidation therapy to strengthen the response, and maintenance therapy to keep the cancer from returning. Each phase uses different combinations of drugs and treatment schedules.

Patients are grouped based on their specific type of ALL and genetic characteristics. The study also includes follow-up to monitor long-term outcomes and any potential side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in a related screening study and consent to participate.
  • Specific white blood cell count criteria based on age.
  • Newly diagnosed with B acute lymphoblastic leukemia (ALL), including patients with Down syndrome.
  • Must meet organ function requirements if they have a specific genetic mutation sensitive to targeted treatments.
  • Adequate kidney and liver function as determined by specific tests.
  • Heart function must be within normal limits.
  • No major heart conduction issues unless a pacemaker is present.
  • No breathing difficulties at rest and good oxygen levels if needed.
  • Seizure disorders must be well-controlled with medication.
  • Must be between 6 and 13 years old for certain cognitive assessments.
  • Must speak English, French, or Spanish.
  • No significant visual impairments.
  • Must meet specific criteria if previously enrolled in a related study.
  • Must sign informed consent and meet all regulatory requirements.

Exclusion Criteria

  • No prior chemotherapy for the current diagnosis or any previous cancer.
  • Not eligible if they have a specific genetic fusion (BCR-ABL1) after induction therapy.
  • Pregnant or breastfeeding females are not eligible.
  • Females 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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