Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL

Launched by PETHEMA FOUNDATION · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for adults diagnosed with Philadelphia-positive acute lymphoblastic leukemia (ALL), a type of blood cancer. The goal is to see how effective and safe the treatment is when using a combination of low-dose chemotherapy and a medication called imatinib, which targets specific cancer cells. The study will also evaluate how well patients respond to the treatment and monitor any side effects they may experience.

To participate in this trial, you must be at least 18 years old and diagnosed with Philadelphia-positive ALL. If you are in good health overall, with no severe organ problems, you might be eligible. Participants will initially receive treatment to help achieve remission, and depending on their response, they may continue with the same treatment or receive more intensive care. It's important to note that the trial is not yet recruiting patients, so there will be more information available once it starts. If you or a loved one are considering participation, this study aims to better understand how to treat this specific type of leukemia effectively.

Gender

ALL

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.