Status:
COMPLETED
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 grow...
Detailed Description
PRIMARY OBJECTIVES: I. Estimate the disease-free survival (DFS) and overall survival (OS) profiles in newly diagnosed patients 18 years or older who have Philadelphia chromosome positive (Ph+) (BCR/(...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01256398
Start Date
December 14 2010
End Date
November 15 2021
Last Update
April 4 2023
Active Locations (101)
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1
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
2
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301
4
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304