Clinical trial · Interventional
First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Ph-Positive ALL
A Phase 2 Multicenter Study of First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified Hyper-CVAD + Dasatinib
- description
- Dasatinib: 100 mg once daily, PO, for 4 weeks Cyclophosphamide: 300 mg/m2, IV, every 12 hours, days 1\~3 Vincristine: 1.4 mg/m2/day (maximum 2 mg/day), IV, days 4 \& 11 Daunorubicin: 45 mg/m2/day, IV, days 4 \& 11 Dexamethasone: 40 mg/day, IV, days 1\~4 \& days 11\~14 Cytarabine: 2 g/m2, IV, every 12 hours, days 1\~5 Mitoxantrone: 12 mg/m2/day, IV, days 1\~2
- interventionNames
- Drug: Dasatinib
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Daunorubicin
- Drug: Dexamethasone
- Drug: Cytarabine
- Drug: Mitoxantrone
Primary outcomes (1)
- measure
- To determine the clinical efficacy of dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive ALL in terms of major molecular response rate
- timeFrame
- by the second 4-week dasatinib therapy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia (karyotypic or molecular evidence of Ph) * Ages of 15-65 years * Eastern Cooperative Oncology Group performance status of 0-2 * Adequate renal (serum creatinine less than 2 mg/dl, unless considered due to leukemia) and hepatic (serum bilirubin less than 3 mg/dl, unless considered due to leukemia) functions * Adequate cardiac status (New York Heart Association Class less than or equal to 2) * Signed informed consent Exclusion Criteria: * Pregnant and lactating women will not be eligible. Women of childbearing potential should have a negative pregnancy test prior to entering on the study. * Active cardiac dysfunction (New York Heart Association Class more than or equal to 3), uncontrolled angina, myocardial infarction (within 6 months), congenital long QT syndrome, any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia or ventricular fibrillation), or prolonged QTc interval on pre-entry electrocardiogram (more than 470 msec) * Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia * Patients with severe medical conditions that in the view of the investigator prohibits participation in the study * Treatment with any other investigational antileukemic agents in the last 30 days before study entry
References
Publications (1)
- DERIVEDYoon JH, Yhim HY, Kwak JY, Ahn JS, Yang DH, Lee JJ, Kim SJ, Kim JS, Park SJ, Choi CW, Eom HS, Park SK, Choi SY, Kim SH, Kim DW, Lee S. Minimal residual disease-based effect and long-term outcome of first-line dasatinib combined with chemotherapy for adult Philadelphia chromosome-positive acute lymphoblastic leukemia. Ann Oncol. 2016 Jun;27(6):1081-1088. doi: 10.1093/annonc/mdw123. Epub 2016 Mar 6. PMID 26951627