Clinical Trial TitleA phase 4, open-label, randomized study of two inotuzumab ozogamicin dose levels in adult patients with relapsed or refractory b-cell ALL eligible for hematopoietic stem cell transplantation and who have risk factor(s) for veno-occlusive disease.
National Clinical Trial Number:NCT03677596
Clinical Trial Protocol Description:
The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have relapsed or refractory precursor CD22-positive B-cell ALL with M2 or M3 marrow (5% blasts) and who are eligible for HSCT.
- Have 1 or more of the following risk factors for developing VOD:
- Due to receive Salvage 2 or greater
- Prior HSCT
- Age > 55 years
- Ongoing or prior hepatic disease which may include a prior history of hepatitis or drug-induced liver injury, as well as hepatic steatosis, nonalcoholic steatohepatitis, baseline elevations of bilirubin > upper limit of normal (ULN) and 1.5 x ULN.
- Ph+ ALL patients: Have failed treatment with at least 1 second or third generation tyrosine kinase inhibitor and standard multi-agent induction chemotherapy.
- Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
- Have lymphoblastic lymphoma and bone marrow involvement 5% lymphoblasts by morphologic assessment.
- Are age 18 years to 75 years.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Have adequate liver function, including total serum bilirubin < 1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN.
- Have serum creatinine < 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of > 40 mL/min.
- Male and female patients of childbearing potential and at risk for pregnancy: Agree to use a highly effective method of contraception throughout the study and for a minimum of 8 months (females) and 5 months (males) after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
- Have undergone a documented hysterectomy and/or bilateral oophorectomy.
- Have medically confirmed ovarian failure.
- All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
- Have evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Patients with mental capacity which requires the presence of a legally authorized representative will be excluded from the study.
- Are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.