Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

• Status: Active, not recruiting
• Trial end date: 2022-08-25
• Target enrollment: 0
• Participant gender: All

Summary

This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Alemtuzumab; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; BB 1101; Calcium; Calcium, Dietary; Cyclophosphamide; Cytarabine; Dasatinib; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Folic Acid; Immunoglobulins; Lenograstim; Leucovorin; Levoleucovorin; Mechlorethamine; Melphalan; Mercaptopurine; Methotrexate; Nitrogen Mustard Compounds; Tacrolimus; Vincristine

Criteria

Inclusion Criteria:

• Unequivocal histologic diagnosis of ALL

• Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or fluorescent in situ hybridization [FISH]) in a Cruise Lines International Association (CLIA)-approved laboratory

• No prior therapy except up to one week of corticosteroids and/or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL

• Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry

• Left ventricular ejection fraction >= lower limit of institutional normal

• No myocardial infarction within 6 months

• No ventricular tachyarrhythmia within 6 months

• No major conduction abnormality (unless a cardiac pacemaker is present)