Clinical trial · Interventional
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
- 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)
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.
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 Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| daunorubicin | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| L-Asparaginase | Drug | Asparaginase | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| Tyrosine kinase inhibitor | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.
- interventionNames
- Drug: vincristine
- Drug: daunorubicin
- Drug: cyclophosphamide
- Drug: L-Asparaginase
- Drug: prednisone
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: dexamethasone
- Drug: Tyrosine kinase inhibitor
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- up to 5 years
- description
- From the date of diagnosis until the date of death from any cause,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged above 14 years with acute leukemia of ambiguous lineage . 2. Eastern Cooperative Oncology Group (ECOG) Performance status 2. 3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan). 4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN 5. Patients should sign informed consent form. Exclusion Criteria: 1. Impaired cardiac function: Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (\<50 beats per minute); ejection fraction \< 45 % on MUGA scan. Corrected QT (QTc) interval \> 450 msec on baseline ECG (using the QTcF formula). If QTcF interval\>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). 2. Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease. 3. Patients who are: (a) pregnant and (b) breast feeding.
References
Publications (0)
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