TheranosticTrials.org

Clinical Trial · NCT03441048

Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia

Overview

This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose, recommended phase 2 dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design with a five-patient cohort at the recommended phase 2 dose.

Sponsor

Medical College of Wisconsin

Phase

Phase 1

Contacts

Sameem Abedin, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03441048

Eligibility

Inclusion

  • Morphologically documented primary AML or secondary AML \[from prior conditions such as Myelodysplastic Syndrome (MDS), myeloproliferative neoplasm (MPN)\] or therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • Greater than 25% of blasts must be CD33 positive on flow cytometry using Phycoerythrin (PE) labeled anti-CD33 antibody.
  • Total bilirubin ≤ 2 x the upper limit of the normal range (ULN)
  • Resting left ventricular ejection fraction (LVEF) \> 40%
  • Patients must meet the following clinical laboratory criteria:
  • In first or subsequent relapse or refractory status after prior therapy, with or without prior hematopoietic stem cell transplant (HSCT). Patients with MDS and progression to AML on hypomethylating agents will also be included.
  • Female patients must agree to avoid becoming pregnant, and male patients should avoid impregnating a female partner.
  • Calculated creatinine clearance ≥ 50 mL/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.

Exclusion

  • Pregnant or breast feeding women.
  • Active severe infection not well controlled by antibacterial or antiviral therapy.
  • Patients with documented pulmonary disease, with a diffusing capacity of the lungs for carbon monoxide (DLCO) and/or forced expiratory volume in one second (FEV1) \<65%, or history of dyspnea at rest, or requiring oxygen.
  • Known infection with human immunodeficiency virus.
  • Prior chemotherapy or radiotherapy within 14 days of study entry unless fully recovered from adverse effects due to treatment, at investigator's discretion.
  • Acute Promyelocytic Leukemia.