At a glance
ClinicalIndex Comparison Record- ✓Ph-positive and/or BCR-ABL positive acute lymphoblastic leukemia, including: newly diagnosed (before or after cytogenetics known), patients after 1-2 courses of chemotherapy ± imatinib, or relapsed ALL/lymphoid blast phase CML
- ✓ECOG performance status 0, 1, or 2
- ✓Adequate cardiac function as assessed clinically
- ✓Adequate hepatic function
- ✕Active serious infection not controlled by antibiotics
- ✕Investigational antileukemic or chemotherapy agents within 7 days prior to entry (unless full recovery or rapidly progressive life-threatening disease)
- ✕Active secondary malignancy expected to shorten survival to <1 year (excluding non-melanoma skin cancer)
- ✕Significant cardiac disease: NYHA grade III-V cardiac failure, uncontrolled angina, MI within 6 months, congenital long QT syndrome, clinically significant ventricular arrhythmias, QTc >470 msec, or concurrent Torsades de Pointes-risk drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Cytarabine, and 6 other interventions for Acute Lymphoblastic Leukemia and 5 related conditions. Completed, enrolled 107 participants across 1 site.
Detailed Summary
This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
Study Details
Timeline
Interventions
Given IV
Given IV or IT
Given PO
Given IV or PO
Given IV
Given IV or IT
Given PO
Given IV