Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|M.D. Anderson Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Tapan M Kadia|
|Principal Investigator Affiliation||M.D. Anderson Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being 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|
|Study Website:||View Trial Website|
- I. To determine the dose limiting toxicity (DLT) and minimum safe and biologically-effective dose of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS).
- II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug administration.
- I. To observe the anti-leukemia effects of Hu8F4 in patients with leukemias and MDS.
- II. To measure the overall survival, disease-free survival and event-free survival of patients with leukemias or MDS treated with Hu8F4.
Experimental: Treatment (Hu8F4)
Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: - Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4
Other: - Laboratory Biomarker Analysis
Other: - Pharmacological Study
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Augusta, Georgia, 30912
Jorge Cortes, MD
Active, not recruiting
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, 10467
M D Anderson Cancer Center
Houston, Texas, 77030
Tapan M. Kadia
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Tibor Kovacsovics, MD