Study on Combining Dasatinib or Imatinib with Chemotherapy and Blinatumomab for Young Patients with Specific Types of B-cell Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06124157
This clinical trial is exploring a new treatment approach for children, adolescents, and young adults with certain types of B-cell acute lymphoblastic leukemia (B-ALL) that have specific genetic markers. The study tests whether adding the drugs dasatinib or imatinib to chemotherapy and blinatumomab can improve treatment outcomes.
Patient Parameters
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Program Overview
This study is testing a new combination of treatments for young patients with specific types of B-cell acute lymphoblastic leukemia (B-ALL) that have certain genetic markers, known as Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like). The treatment combines standard chemotherapy with blinatumomab, a drug that helps the immune system attack cancer cells, and either dasatinib or imatinib, which are drugs that block signals that make cancer cells grow. The goal is to see if this combination works better than the current standard treatments.
Description
The main goal of this study is to see if the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy can improve the chances of staying cancer-free for three years in young patients with newly diagnosed Ph+ or ABL-class Ph-like B-ALL. The study will also look at the safety of this treatment combination and any side effects it may cause, such as infections or delays in treatment.
The study is divided into different parts, where patients will receive various treatments over time. These include cycles of chemotherapy, blinatumomab, and either dasatinib or imatinib, depending on the specific genetic markers of their leukemia. The treatment plan is designed to be as effective as possible while minimizing side effects.
Throughout the study, patients will undergo regular tests and evaluations to monitor their response to the treatment and any side effects. This includes blood tests, imaging scans, and bone marrow biopsies. The study aims to provide valuable information on whether this new treatment approach can improve outcomes for young patients with these specific types of leukemia.
Eligibility Criteria
Inclusion Criteria
- Age between 1 and 46 years, depending on the study group.
- Newly diagnosed with Ph+ or ABL-class Ph-like B-ALL, with specific genetic markers confirmed by tests.
- Started initial treatment with certain chemotherapy drugs but not more than 14 days of treatment for Ph+ B-ALL or 35 days for ABL-class Ph-like B-ALL.
- Good overall health with a performance status score of 50% or higher.
- Adequate kidney and liver function as determined by specific tests.
- Heart function within normal limits as shown by heart tests.
- Willing to follow study procedures and provide informed consent.
Exclusion Criteria
- History of chronic myeloid leukemia (CML).
- Certain central nervous system conditions at the end of initial treatment phase.
- Previous cancer treated with chemotherapy.
- Active infections or serious illnesses requiring intensive medical support.
- Down syndrome (trisomy 21).
- Pregnant or breastfeeding women.
- Not willing to use effective birth control during and after treatment.
- Previous treatment with certain cancer drugs, except for imatinib or dasatinib.
- Heart conditions that could interfere with treatment.
- Certain neurological conditions that could interfere with treatment.
- HIV-positive patients not on effective treatment.
- Must meet all regulatory requirements and provide informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| Lucile Packard Children's Hospital Stanford University | 94304 | Palo Alto | California |
| Rady Children's Hospital - San Diego | 92123 | San Diego | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Yale University | 06520 | New Haven | Connecticut |
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