Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06175702
Eligibility Criteria:
Inclusion Criteria:
1. Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.
2. CML blast crisis will be included. These patients will always receive transplantation, regardless of the molecular response or the genetic risk, following the recommendations of the SEHH CML group (Chronic Myleoid Leukemia Group from the Spanish Society of Hematology).
3. Performance status 0-2; patients with performance status\>2 attributable to ALL can be included.
4. Patients without functional alteration of organs; liver function: total bilirubin, GOT, GPT, GGT and alkaline phosphatase less than 3 times the upper limit of the normal range of the laboratory; renal function: serum creatinine \<2 mg/dl or creatinine clearance \> 30 ml/min (except altered renal function attributable to ALL); normal heart function: EF ventricular \> 50%; absence of severe chronic respiratory disease. In case that the alterations are secondary to the disease, it is at the discretion of the physician to determine if the patient can be included in the study.
Exclusion Criteria:
1. Any other subtype of ALL.
2. Patients with chronic liver disease.
3. Patients with chronic respiratory failure.
4. Renal failure not due to ALL.
5. Lipase and amylase\>1.5× ULN.
6. Patients with positive HIV serology.
7. Serious neurological alterations not due to ALL.
8. Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.
9. Pregnant or breastfeeding women.
10. Impaired cardiac function (defined by an ejection fraction less than 50%), any clinically significant active or uncontrolled cardiovascular condition, uncontrolled hypertension, arrhythmias, ischemic cardiovascular or neurological events, deep vein thrombosis, pulmonary thromboembolism, history of acute pancreatitis in the year before diagnosis of ALL or history of chronic pancreatitis and triglycerides \>450 mg/dL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06175702
Study Brief:
Protocol Section:
NCT06175702