Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vincristine, daunorubicin, cyclophosphamide, L-Asparaginase.
- Who it may be relevant to
- Registry conditions: Acute Leukemia of Ambiguous Lineage. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Overall survival (OS) [Time frame: up to 5 years]
Secondary outcome measures (3)
- Relapse free survival (RFS) [Time frame: up to 5 years]
- The complete remission (CR) rate [Time frame: up to 2.5 years]
- Mortality within 60 days [Time frame: up to 60 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- HBDH — Tianjin
Identifiers
NCT: NCT04440267 · IIT2020009