NCT02530034TerminatedPhase 1
Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 19 Aug 2015
- Start date
- 31 Jan 2019
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Myeloproliferative neoplasms, Chronic myeloid leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia
- NCT number
- NCT02530034
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From 31 Jan 2019 to the primary completion date, 15 Oct 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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
Other illness
- 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 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
Other
- Patients with known central nervous system infiltration with leukemia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Montefiore Medical Center-Albert Einstein College of Medicine Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.