Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases

NCT00038857

Leukemia Lymphoma

COMPLETED PHASE2

Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia

NCT00001144

Chronic Myeloid Leukemia Graft vs Host Disease

COMPLETED PHASE2

Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

NCT01904136

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Acute Myeloid Leukemia With Gene Mutations +6 more

COMPLETED PHASE1/PHASE2

Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

NCT00038779

Leukemia Non Hodgkin's Lymphoma Aplastic Anemia

TERMINATED NA

IFN-γ to Treat Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) That Has Relapsed After Allogeneic Hematopoietic Stem Cell Transplantation

NCT04628338

Myelodysplastic Syndromes Myeloid Leukemia Allogeneic Stem Cell Transplantation

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE: This is a dose-escalation study.

Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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 Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4

Intervention Type DRUG

Given IV

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Pharmacological Study

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4

Given IV

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Pharmacological Study

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hu8F4

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No