Study on Chemotherapy With or Without Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02003222
This clinical trial is exploring whether adding the immunotherapy drug blinatumomab to standard chemotherapy can improve treatment outcomes for patients with a specific type of newly diagnosed acute lymphoblastic leukemia (ALL).
Patient Parameters
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Program Overview
This study is investigating if combining the immunotherapy drug blinatumomab with standard chemotherapy is more effective than chemotherapy alone in treating patients with a newly diagnosed type of acute lymphoblastic leukemia (ALL) that does not have the BCR-ABL gene mutation. Chemotherapy works by killing cancer cells or stopping them from growing, while blinatumomab helps the immune system attack cancer cells. The study aims to find out if this combination can improve survival and reduce the chance of cancer returning.
Description
The main goal of this study is to compare the survival rates of patients receiving chemotherapy with blinatumomab to those receiving chemotherapy alone. Researchers will also look at how long patients remain free from cancer after treatment and assess any side effects of the treatments.
Patients will first receive induction chemotherapy, which includes several drugs given in specific cycles to reduce cancer cells. After this, patients will be randomly assigned to receive either blinatumomab with chemotherapy or chemotherapy alone. The study will also evaluate the safety of these treatments and their effects on patients' health.
Throughout the study, patients will undergo various tests, including blood tests, bone marrow exams, and imaging scans, to monitor their response to treatment. After completing the study treatment, patients will have regular follow-up visits to check their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be between 30 and 70 years old.
- Newly diagnosed with a specific type of acute lymphoblastic leukemia (ALL) without the BCR-ABL gene mutation.
- Must have adequate liver and kidney function.
- Must not have any other active cancer or serious medical conditions that could affect treatment.
- Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study.
- Men must agree to use effective contraception if their partner is of childbearing potential.
- Must be able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Cannot have a different type of leukemia known as Burkitt's-like leukemia.
- Cannot have another active cancer being treated.
- Cannot have serious organ damage or medical issues that could affect treatment.
- Cannot have a history of significant brain or nervous system disorders, such as epilepsy or severe brain injuries.
- Cannot have an active, uncontrolled infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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