About this study
Acute lymphoblastic leukemia and acute lymphoblastic lymphoma are cancers of blood cells. They are often known simply as ALL and LLy. These cancers are alike in many ways. Their treatments are also similar.
Both ALL and LLy grow quickly and need to be treated immediately with a combination of anti-cancer drugs, known as chemotherapy. Previous studies have shown that most children with ALL can have a long-term remission if they get strong chemotherapy with several drugs.
In this study, children will be assigned to receive a specific treatment based on their level of risk and disease cell type. Risk refers to the chance of the disease coming back after therapy. Cell type refers to the type of white blood cell that is affected: B-cell or T-cell.
Some study participants with B-cell ALL and LLy may be eligible for a type of immunotherapy called CAR T-Cell Therapy. This treatment is designed to help the body recognize and fight diseases. Other patients in the study may be given blinatumomab, an immunotherapy drug. The U.S. Food and Drug Administration (FDA) has approved this drug to treat adults and children with ALL that has not responded to treatment (refractory) or has come back after treatment (relapsed). The FDA has not approved blinatumomab for patients with newly diagnosed ALL or LLy.
Patients in this clinical trial will be treated in three stages over approximately 2½ years:
- Remission induction – Doctors try to remove all visible signs of disease and allow normal blood cells to be restored.
- Consolidation – Doctors try to deliver a “knock-out punch” to any remaining disease cells.
- Continuation – Doctors try to keep the disease from coming back.
Eligibility overview
- Diagnosis of B-cell or T-cell acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy)
- 1 to 18 years old
- No prior therapy or limited prior therapy