Actively Recruiting
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
50
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of chemotherapy based on acute lymphoblastic leukemia (ALL) in patients diagnosed with acute leukemia of ambiguous lineage. This prospective, single arm, open label clinical trial will enroll 50 patients aged 14 years and older. The study also investigates how genetic abnormalities and minimal residual disease (MRD) impact patients' prognosis. Participants will receive ALL-based chemotherapy, which includes drugs such as vincristine, daunorubicin, cyclophosphamide, L-Asparaginase, prednisone, mercaptopurine, methotrexate, dexamethasone, and tyrosine kinase inhibitors for those with the t(9;22) genetic abnormality. Patients who achieve complete remission (CR) may receive allogeneic hematopoietic stem cell transplantation (HSCT); otherwise, they will complete consolidation chemotherapy. During the trial, participants will be monitored for overall survival up to five years, relapse-free survival also up to five years, complete remission rates up to 2.5 years, and mortality within 60 days. The study includes ongoing assessments of genetic factors and minimal residual disease to understand their effects on outcomes. Participants will undergo regular clinical evaluations and laboratory tests to track treatment response and safety throughout the study period.
CONDITIONS
Brief Title
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged above 14 years with acute leukemia of ambiguous lineage.
- Eastern Cooperative Oncology Group (ECOG) Performance status 2.
- Adequate organ function: Total bilirubin 64 1.5 x upper limit of normal (ULN); SGOT and SGPT 64 2.5 x ULN; Creatinine 64 1.5 x ULN; Serum amylase and lipase 64 1.5 x ULN; Alkaline phosphatase 64 2.5 x ULN unless tumor related.
- Adequate cardiac function with ejection fraction 5 45% on MUGA scan.
- Laboratory values at or above lower limit of normal for potassium, magnesium, and phosphorus.
- Signed informed consent form.
You will not qualify if you...
- Impaired cardiac function including long QT syndrome, resting brachycardia (<50 bpm), ejection fraction <45%, QTc interval >450 msec on baseline ECG, recent myocardial infarction within 12 months, unstable angina, congestive heart failure, uncontrolled hypertension, or uncontrolled arrhythmias.
- Other severe or uncontrolled medical conditions such as another primary malignant disease requiring treatment, acute or chronic liver, pancreatic, or severe renal disease, or other life-threatening illnesses.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2.5 years or until completion of consolidation chemotherapy or HSCT
Participants receive acute lymphoblastic leukemia (ALL)-based chemotherapy. Those with t(9;22) receive chemotherapy combined with tyrosine kinase inhibitors. Some participants may undergo allogeneic hematopoietic stem cell transplantation (HSCT) if in complete remission.
Visit schedule varies based on chemotherapy cycles and transplantation timing
Duration - Up to 5 years
Participants are monitored for overall survival, relapse-free survival, and long-term health outcomes after treatment completion.
Periodic visits for assessments over 5 years
Trial Site Locations
Total: 1 location
1
HBDH
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
Jianxiang Wang, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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