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

Completed · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

In brief

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.

Key facts

Study ID

NCT01256398

Run by

National Cancer Institute (NCI)

People needed

66

Starts

2010-12-14

Expected to finish

2021-11-15

Last updated by the study team

2023-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Western States Cancer Research NCORP — Denver, Colorado, United States
• Mercy Medical Center — Durango, Colorado, United States
• Mountain Blue Cancer Care Center - Swedish — Englewood, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Mountain Blue Cancer Care Center — Golden, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Rocky Mountain Cancer Centers-Greenwood Village — Greenwood Village, Colorado, United States
• Rocky Mountain Cancer Centers-Lakewood — Lakewood, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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