Clinical trial · Interventional
Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients
The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
- 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 aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.
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 |
|---|---|---|---|
| ph+ Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ph+ ALL with dasatinib
- description
- patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy.
- interventionNames
- Drug: Dasatinib
- Drug: prednisone
- Drug: dexamethasone
- Drug: methotrexate
Primary outcomes (1)
- measure
- The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
- timeFrame
- 115 days
Secondary outcomes (1)
- measure
- Time needed to achieve MMR
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Get signed the informed consent of patients and family members 2. Age ≥ 18 one full year of life 3. Confirm the ph + ALL at molecular biology level 4. Normal heart and lungs function 5. Normal liver and kidney function Exclusion Criteria: 1. Leukemia in the nervous system 2. Recurrent patients 3. Allergies associated with any drug in our research 4. At the same time with other organs' malignant tumours 5. participating in other clinical researches at the same time
References
Publications (2)
- RESULTFujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20. PMID 24357015
- DERIVEDPeng Y, Huang J, Yin J, Meng F, Cao Y, Huang L, Li D, Zhang Y, Zhang D, Meng L, Han Z, Hong Z. Frontline combination of dasatinib and low-intensity chemotherapy in adults with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia. Expert Rev Hematol. 2024 Apr-May;17(4-5):173-180. doi: 10.1080/17474086.2024.2343885. Epub 2024 Apr 24. PMID 38616308