Status:
COMPLETED
Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 chemothe...
Detailed Description
Relapsed/refractory acute myeloid leukemia (RR-AML) in adults is an important therapeutic challenge. Nearly 60% of AML patients ultimately relapse or have refractory disease, and failure to achieve re...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of informed consent.
- 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.
- 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.
- 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.
- Patients must meet the following clinical laboratory criteria:
- Total bilirubin ≤ 2 x the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Calculated creatinine clearance ≥ 50 mL/min
- Resting left ventricular ejection fraction (LVEF) \> 40%
- Female patients must agree to avoid becoming pregnant, and male patients should avoid impregnating a female partner.
Exclusion
- Acute Promyelocytic Leukemia.
- Active severe infection not well controlled by antibacterial or antiviral therapy.
- Known infection with human immunodeficiency virus.
- 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.
- Pregnant or breast feeding women.
- Prior chemotherapy or radiotherapy within 14 days of study entry unless fully recovered from adverse effects due to treatment, at investigator's discretion.
- Active malignancy within 2 years of entry, except previously treated melanoma grade 2 or less, non-melanoma skin cancer, carcinoma in situ, or cervical intraepithelial neoplasia, and organ confined prostate cancer with no evidence of progressive disease based on prostate-specific antigen (PSA) levels and are not on active therapy. Active malignancy is malignancy receiving treatment.
Key Trial Info
Start Date :
May 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03441048
Start Date
May 22 2018
End Date
May 22 2024
Last Update
October 8 2024
Active Locations (1)
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1
Froedtert Hospital and the Medical College of Wisconsin
Milwuakee, Wisconsin, United States, 53226