Phase 2
N=66
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia · Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Bottom Line
View on ClinicalTrials.gov: NCT01256398 ↗Enrolled (actual)
66
Serious AEs
7.7%
Results posted
May 2019
Primary outcome: Primary: Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause — 52.6 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alemtuzumab (Biological); Allogeneic Hematopoietic Stem Cell Transplantation (Procedure); Autologous Hematopoietic Stem Cell Transplantation (Procedure); Cyclophosphamide (Drug); Cytarabine (Drug); Dasatinib (Drug); Daunorubicin Hydrochloride (Drug); Dexamethasone (Drug); Etoposide Phosphate (Drug); Filgrastim (Biological); Fludarabine Phosphate (Drug); In Vitro-Treated Peripheral Blood Stem Cell Transplantation (Procedure); Laboratory Biomarker Analysis (Other); Leucovorin Calcium (Drug); Melphalan (Drug); Mercaptopurine (Drug); Methotrexate (Drug); Pegfilgrastim (Biological); Pharmacological Study (Other); Tacrolimus (Drug); Vincristine Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause |
52.6 | — |
| SECONDARY Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) |
0.667 | — |
| SECONDARY Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. |
5 | — |
| SECONDARY Overall Survival (OS) |
55.9 | — |
| SECONDARY Disease Free Survival (DFS) |
29.7 | — |
| SECONDARY Response |
.9846 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01256398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.