Last updated: March 1, 2023
Sponsor: Institute of Hematology & Blood Diseases Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Treatment
N/AClinical Study ID
NCT05660473
IIT2022052-EC-1
Ages 14-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by thebone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biologyaccording 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 aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present;Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN;Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection 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, potentiallyinterfere with the completion of treatment
Study Design
Total Participants: 100
Study Start date:
October 31, 2022
Estimated Completion Date:
December 30, 2027
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.