Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jun 17, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a type of cancer called acute leukemia of ambiguous lineage. The study will enroll 50 participants who are 14 years or older and will provide them with chemotherapy based on a treatment used for acute lymphoblastic leukemia (ALL). If patients achieve a complete remission, they may also have the option to receive a stem cell transplant. The trial aims to understand how effective this chemotherapy is and how certain genetic factors and the presence of minimal residual disease (which refers to small amounts of cancer that may remain after treatment) can affect the patients' outcomes.

To be eligible for this trial, patients need to be above 14 years old, have a specific performance status indicating they can tolerate treatment, and show that their organs are functioning well. Those with serious heart conditions or other severe health issues will not be able to participate. Participants will receive thorough medical care and monitoring throughout the trial, and they will need to sign a consent form to join. This trial is not yet recruiting, so it will be important for interested individuals to keep an eye out for when enrollment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged above 14 years with acute leukemia of ambiguous lineage .
• • 2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.
• • 3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
• • 4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
• • 5. Patients should sign informed consent form.
• Exclusion Criteria:
• 1. Impaired cardiac function:
• • Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (\<50 beats per minute); ejection fraction \< 45 % on MUGA scan. Corrected QT (QTc) interval \> 450 msec on baseline ECG (using the QTcF formula). If QTcF interval\>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
• 2. Other concurrent severe and/or uncontrolled medical conditions:
• • Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
• • 3. Patients who are: (a) pregnant and (b) breast feeding.