Status:
NOT_YET_RECRUITING
Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL
Lead Sponsor:
PETHEMA Foundation
Conditions:
Lymphoblastic Leukemia
Philadelphia-Positive ALL
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved com...
Detailed Description
The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved com...
Eligibility Criteria
Inclusion
- Patients with de novo avute lymphoblastic leukeima (ALL) Philadelphia chromosome-positive (BCR::ABL1) aged ≥18 years.
- 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).
- Performance status 0-2; patients with performance status\>2 attributable to ALL can be included.
- 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
- Any other subtype of ALL.
- Patients with chronic liver disease.
- Patients with chronic respiratory failure.
- Renal failure not due to ALL.
- Lipase and amylase\>1.5× ULN.
- Patients with positive HIV serology.
- Serious neurological alterations not due to ALL.
- Serious general condition condition (grades 3 or 4 on the WHO scale) not attributable to ALL.
- Pregnant or breastfeeding women.
- 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.
Key Trial Info
Start Date :
December 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 25 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06175702
Start Date
December 25 2023
End Date
December 25 2030
Last Update
December 19 2023
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