Phase
Condition
Leukemia
Treatment
Dexamethasone
Prednisone
6-mercaptopurine
Clinical Study ID
Ages 14-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed bythe bone marrow cytomorphology, immunophenotyping, cytogenetics and molecularbiology according to WHO classification
Age: 14 -60 years
Male or female
ECOG Performance Status 0-2
Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit ofnormal(ULN); serum alanine aminotransferase (ALT) and serum aspartateaminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liveris present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkalinephosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes:Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasoundejection fraction ≥ 45%;
Subject has provided written informed consent prior to any screening procedure
Exclusion
Exclusion Criteria:
Burkitt lymphoma/leukemia
Acute Leukemia of Ambiguous Lineage
Female patients who are pregnant or breast feeding
Uncontrolled active serious infections that could, in the investigator's opinion,potentially interfere with the completion of treatment
History of pancreatitis
Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of >7.5%. Patients with preexisting, well-controlled diabetes are not excluded
History of active gastrointestinal bleeding within the last 6 months
History of arterial/venous thrombosis within the last 6 months
Known HIV seropositivity
Any serious psychiatric illness that could, in the investigator's opinion,potentially interfere with the completion of treatment
Study Design
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
ChinaActive - Recruiting

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