Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: single arm 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
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: daunorubicin
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: cyclophosphamide
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: L-Asparaginase
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: prednisone
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: mercaptopurine
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: methotrexate
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: dexamethasone
acute lymphoblastic leukemia (ALL) -based chemotherapy
Drug: Tyrosine kinase inhibitor
acute lymphoblastic leukemia (ALL) -based chemotherapy
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [up to 5 years]
From the date of diagnosis until the date of death from any cause,
Secondary Outcome Measures
- Relapse free survival (RFS) [up to 5 years]
From the date of CR until the date of relapse or death
- The complete remission (CR) rate [up to 2.5 years]
Incidence of complete remission after induction chemotherapy
- Mortality within 60 days [up to 60 days]
Proportion of patients died within 60 days
Other Outcome Measures
- Chromosomal abnormalities detected by G-banding [Baseline]
- Fusion genes detected by polymerase chain reaction [Baseline]
- Mutations detected by next-generation sequencing [Baseline]
- Minimal residual disease(MRD) [1 year]
The presence of small numbers of leukemic cells detected by the flow cytometry after remission
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged above 14 years with acute leukemia of ambiguous lineage .
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Eastern Cooperative Oncology Group (ECOG) Performance status 2.
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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).
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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
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | HBDH | Tianjin | Tianjin | China | 300020 |
Sponsors and Collaborators
- wang, jianxiang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IHBDH-IIT2020009-EC-1