Study on Combination Chemotherapy With or Without Donor Stem Cell Transplant for Treating Acute Lymphoblastic Leukemia

Program Overview

This study is investigating whether using a combination of chemotherapy drugs, with or without a donor stem cell transplant, can effectively treat patients with acute lymphoblastic leukemia (ALL). Chemotherapy drugs work by stopping cancer cells from growing or dividing. When used together, they may be more effective at killing cancer cells. Before a stem cell transplant, chemotherapy and total-body irradiation are used to stop cancer cell growth and prevent the patient's immune system from rejecting the donor's stem cells. The donor stem cells can help replace the patient's immune cells and attack any remaining cancer cells.

Description

The study has several goals:

• Primary Goal: To see if patients with a specific type of ALL (Philadelphia chromosome positive and/or BCR/ABL positive) have better survival rates after receiving a combination of chemotherapy drugs and a tyrosine kinase inhibitor called dasatinib, followed by a donor stem cell transplant.

• Secondary Goals: To check if patients who haven't been treated before can stay in complete remission after receiving the same combination of drugs. Also, to compare two methods of detecting minimal residual disease (MRD) to predict patient outcomes.

• Tertiary Goals: To estimate the frequency and severity of side effects from the chemotherapy regimen and to assess the overall survival of all patients in the study.

Treatment Plan:

• Induction/Consolidation Therapy: Patients receive alternating courses of chemotherapy drugs, including cyclophosphamide, doxorubicin, vincristine, dexamethasone, dasatinib, cytarabine, methotrexate, and filgrastim. This phase lasts for 8 courses, each 14-21 days long, unless the disease progresses or side effects become unacceptable.

• Maintenance Therapy: If a transplant is not ready, patients receive vincristine, prednisone, and dasatinib every month for up to 24 months.

• Intensification: For certain courses, patients receive additional chemotherapy drugs to intensify treatment.

• Stem Cell Transplant: Patients who achieve complete remission may undergo a donor stem cell transplant, with specific conditioning regimens to prepare the body.

• Graft-Versus-Host Disease Prevention: Patients receive medications to prevent complications after the transplant.

• Single-Agent Therapy: After completing maintenance therapy or 100 days post-transplant, patients may receive dasatinib for up to 5 years.

Patients are followed every 6 months for up to 5 years after completing the study therapy.

Eligibility Criteria

Locations