Clinical trial · Interventional
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG
- 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)
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.
Conditions
Conditions (2)
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 |
| Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | Adult B Acute Lymphoblastic Leukemia with t(9;22)(q34.1;q11.2); BCR-ABL1 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (21)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Daunorubicin Hydrochloride | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, transplant)
- description
- See Detailed Description
- interventionNames
- Biological: Alemtuzumab
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Dasatinib
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Drug: Etoposide Phosphate
- Biological: Filgrastim
- Drug: Fludarabine Phosphate
- Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
- Other: Laboratory Biomarker Analysis
- Drug: Leucovorin Calcium
- Drug: Melphalan
- Drug: Mercaptopurine
- Drug: Methotrexate
- Biological: Pegfilgrastim
- Other: Pharmacological Study
- Drug: Tacrolimus
- Drug: Vincristine Sulfate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDWieduwilt MJ, Yin J, Wetzler M, Uy GL, Powell BL, Kolitz JE, Liedtke M, Stock W, Beumer JH, Mattison RJ, Storrick E, Christner SM, Lewis LD, Devine S, Stone RM, Larson RA. Dasatinib and dexamethasone followed by hematopoietic cell transplantation for adults with Ph-positive ALL. Blood Adv. 2021 Nov 23;5(22):4691-4700. doi: 10.1182/bloodadvances.2021004813. PMID 34492682