Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment

Patients must have histologically or cytologically confirmed diagnosis of MDS by bone marrow biopsy by World Health Organization (2016) guidelines

Patients with MDS who have progressed or had no response after 6 cycles of azacitidine or 4 cycles of decitabine

Patients with MDS must have ≥ 5% myeloblasts

Patients with demonstration of CD33 positive myeloblasts more than 25% on flow cytometry

Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lintuzumab-Ac225 in patients \< 18 years of age, children are excluded from this study

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

Serum direct bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN

Creatinine clearance ≥ 60 mL/min (creatinine clearance \[CrCl\] will be calculated using actual body weight unless the patient is obese \[body mass index (BMI) ≥ 30 kg/m²\], in which case adjusted body weight will be used)

HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better

The effects of lintuzumab-Ac225 on the developing human fetus are unknown. For this reason and because CD33 radiotherapy agents are known to be teratogenic, female patients of childbearing age must have had a negative serum pregnancy test within 14 days of initiation of dosing and must agree to use of two acceptable methods of birth control while on the study drug. A woman must agree to remain on a highly effective method throughout the study and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. During the study and for 3 months after receiving the last dose of study drug, men participating in this trial must use highly effective contraception. Men who are sexually active with a woman of childbearing potential must use a barrier method of contraception, such as a condom, in addition to ensuring use of a highly effective method of contraception. Men who are sexually active with a woman who is pregnant must use a condom. Male participants must also agree not to father a child or donate sperm during the study and for 3 months after receiving the last dose of study drug

Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment

What this study is about

Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment

What this study is about