Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

NCT02530034 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: 2014-0057NCI-2015-02131P-TRP-2447-14P50CA100632
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Minimum safety data

  Safety data will be summarized using frequency and percentage for all patients.

  4 weeks

• Biologically-effective dose

  Safety data will be summarized using frequency and percentage for all patients.

  4 weeks

Secondary Outcomes (4)

• Overall survival

  Up to 4 years

• Disease-free survival

  Up to 4 years

• Event-free survival

  Up to 4 years

• Duration of complete remission

  Up to 4 years

Study Arms (1)

Treatment (Hu8F4)

EXPERIMENTAL

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

Interventions

Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 DRUG

Given IV

Also known as: Hu8F4

Treatment (Hu8F4)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (Hu8F4)

Pharmacological Study OTHER

Correlative studies

Treatment (Hu8F4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Augusta University

Augusta, Georgia, 30912, United States

Location

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Blast Crisis; Hematologic Neoplasms; Primary Myelofibrosis; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Myelodysplastic-Myeloproliferative Diseases

Study Officials

• Tapan M Kadia

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: January 31, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (4)