Status:
RECRUITING
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Leukemia of Ambiguous Lineage
Eligibility:
All Genders
14+ years
Phase:
PHASE2
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) -base...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04440267
Start Date
July 8 2020
End Date
December 20 2027
Last Update
August 6 2025
Active Locations (1)
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1
HBDH
Tianjin, Tianjin Municipality, China, 300020