Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Leukemia of Ambiguous Lineage

Intervention / Treatment
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* Drug: vincristine
* Drug: daunorubicin
* Drug: cyclophosphamide
* Drug: L-Asparaginase
* Drug: prednisone
* Drug: mercaptopurine
* Drug: methotrexate
* Drug: dexamethasone
* Drug: Tyrosine kinase inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged above 14 years with acute leukemia of ambiguous lineage . Eastern Cooperative Oncology Group (ECOG) Performance status 2. 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). 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 Patients should sign informed consent form. Exclusion Criteria: 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). 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. Patients who are: (a) pregnant and (b) breast feeding.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>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. | Drug: vincristine<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: daunorubicin<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: cyclophosphamide<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: L-Asparaginase<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: prednisone<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: mercaptopurine<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: methotrexate<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: dexamethasone<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>Drug: Tyrosine kinase inhibitor<br>* acute lymphoblastic leukemia (ALL) -based chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | From the date of diagnosis until the date of death from any cause, | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival (RFS) | From the date of CR until the date of relapse or death | up to 5 years | 
| The complete remission (CR) rate | Incidence of complete remission after induction chemotherapy | up to 2.5 years | 
| Mortality within 60 days | Proportion of patients died within 60 days | up to 60 days |