Study on Blinatumomab and Chemotherapy for Newly Diagnosed B-Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03914625
This clinical trial is exploring how well the drug blinatumomab works when combined with chemotherapy to treat patients with newly diagnosed B-lymphoblastic leukemia or lymphoma, including those with Down syndrome. The study aims to see if this combination can improve treatment outcomes compared to chemotherapy alone.
Patient Parameters
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Program Overview
This study is testing whether adding the drug blinatumomab to standard chemotherapy can help treat patients with newly diagnosed B-lymphoblastic leukemia or lymphoma. Blinatumomab is a type of monoclonal antibody that may help the immune system fight cancer cells. The trial will also look at different chemotherapy plans based on the risk of cancer returning, to see which patients benefit most from specific treatments.
Description
The main goal of this study is to find out if adding blinatumomab to standard chemotherapy improves the chances of staying cancer-free for patients with standard risk B-lymphoblastic leukemia (B-ALL) and certain higher risk features. The study will also confirm if boys with standard-risk favorable B-ALL can maintain a high survival rate when treated with standard chemotherapy for two years.
Secondary goals include describing survival rates for different patient groups, reducing treatment-related deaths in patients with Down syndrome by replacing some chemotherapy with blinatumomab, and assessing the impact of treatment on neurocognitive function and caregiver burden.
The study will explore immune functions and genetic factors related to infections in children with Down syndrome and B-ALL, as well as the effects of leukemia and its treatment on quality of life. It will also investigate the presence of minimal disease in lymphoma and the genetic makeup of leukemia cells.
Patients will undergo an initial induction treatment, followed by consolidation therapy. Depending on their response and risk factors, they will be assigned to different treatment arms, which may include additional cycles of blinatumomab and chemotherapy. The study will monitor patients' health and treatment response over time.
Eligibility Criteria
Inclusion Criteria
- Patients with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) or B-cell lymphoblastic lymphoma (B-LLy), with or without Down syndrome.
- Age between 1 and 10 years for B-ALL patients without Down syndrome, and up to 31 years for those with Down syndrome or B-LLy patients.
- B-ALL patients without Down syndrome must have an initial white blood cell count below 50,000/uL.
- Patients must have a diagnosis confirmed by bone marrow or blood tests.
- All patients and their guardians must provide informed consent.
- Must meet all institutional and regulatory requirements for human studies.
Exclusion Criteria
- Patients with secondary leukemia after previous cancer treatment.
- Patients who have received prior chemotherapy for the current diagnosis, except for certain pre-treatments.
- Patients with acute undifferentiated leukemia or certain central nervous system or testicular involvement.
- Patients with specific genetic conditions or other types of lymphoma.
- Pregnant or breastfeeding women, and those not using effective contraception.
- Patients with certain medical conditions or requiring radiation at diagnosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
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