Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

Running, not enrolling · Phase 1

Conditions studied: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, High Risk Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome With Excess Blasts-2, Myelofibrosis, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Refractory Chronic Myelomonocytic Leukemia, Secondary Acute Myeloid Leukemia

In brief

This phase I trial studies the side effects and best dose of anti-PR1/HLA-A2 monoclonal antibody Hu8F4 (Hu8F4) in treating patients with malignancies related to the blood (hematologic). Monoclonal antibodies, such as Hu8F4, may interfere with the ability of cancer cells to grow and spread.

Key facts

Study ID: NCT02530034
Run by: M.D. Anderson Cancer Center
People needed: 72
Starts: 2019-01-31
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with any of the following diagnoses are eligible: 1) high-risk MDS (i.e. refractory anemia with excess blasts [RAEB-1 or RAEB-2] by World Health Organization [WHO] classification, or any WHO subset with International Prognostic Scoring System [IPSS] intermediate-2 or high, or any patients that have failed prior therapy with hypomethylating agents); 2) chronic myelomonocytic leukemia (CMML); 3) acute myeloid leukemia (AML) by WHO classification; 4) chronic myeloid leukemia in blast phase (CML-BP); 5) myelofibrosis with high-risk features (e.g., accelerated phase disease -10-19% blasts in peripheral blood or bone marrow-, or with Dynamic International Prognostic Scoring System [DIPSS]-plus high risk score)
Patients must have relapsed/refractory disease and have failed, or are not candidates for, or have declined all available therapies of proven efficacy; they should also not be eligible for at the time of enrollment or have declined hematopoietic stem cell transplantation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
The effects of Hu8F4 on a fetus or nursing child are unknown; women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial; nursing patients are excluded; sexually active men must also use acceptable contraceptive methods for the duration of time on study
Patients must have human leukocyte antigen (HLA)-A2 phenotype
Must be able and willing to give written informed consent
Patients must be at least 2 weeks from prior chemotherapy, radiation therapy, or major surgery, and at least 4 weeks or 5 half lives from other investigational anticancer therapy, and have recovered from prior toxicities at least to grade 1; the exception is hydroxyurea that requires no washout prior to the start of study drug
Clinically significant toxicities from prior chemotherapy must not be greater than grade 1
Clearance creatinine or glomerular filtration rate (GFR) >= 40 mL/min
Total bilirubin =< 1.5 x the upper limit of normal unless considered due to Gilbert's syndrome or leukemic involvement
Alanine aminotransferase (ALT) =< 3 x the upper limit of normal unless considered due to leukemic involvement

You may not qualify if…

Uncontrolled intercurrent illness including, but not limited to uncontrolled infection (patients must have no temperature >= 38.3 degrees Celsius [C] due to infection for at least 48 hrs to consider an infection controlled), psychiatric illness that would limit compliance with study requirements, or active heart disease including confirmed myocardial infarction within previous 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication, or uncontrolled congestive heart failure New York (NY) Heart Association class III or IV
Patients with current active malignancies or any remission for < 18 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may have active disease or be in remission for less than 6 months
Patients receiving any other standard or investigational treatment for their hematologic malignancy other than supportive care
Patients who have had any major surgical procedure within 14 days of day 1
Patients with known central nervous system infiltration with leukemia
Patients who received an allogeneic stem cell transplant =< 90 days from the start of therapy
Patients with active >= grade 3 graft versus host disease (GVHD), or receiving systemic steroids (> 10 mg/day of prednisone or equivalent) for GVHD
Patients with known active central nervous system (CNS) disease; patients with history of active CNS disease should have at least two negative spinal fluid evaluations before being considered eligible

Where it is running

Augusta University — Augusta, Georgia, United States
Montefiore Medical Center, Albert Einstein College of Medicine — The Bronx, New York, United States
M D Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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