Overview

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)