Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 1NCT02530034
Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
A Phase 1 study testing Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4, Laboratory Biomarker Analysis and Pharmacological Study in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4, Laboratory Biomarker Analysis and Pharmacological Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Jan 2019to 1 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Augusta University
Augusta, Georgia, 30912
M D Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
Official title: Phase I Study of Hu8F4 in 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- 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
- Being tested
- Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4, Laboratory Biomarker Analysis, Pharmacological Study
- Medical subject headings
- Blast Crisis, Hematologic Neoplasms, Primary Myelofibrosis, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4Drug
Also called Hu8F4
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum safety data
Safety data will be summarized using frequency and percentage for all patients.
Measured: 4 weeks
Biologically-effective dose
Safety data will be summarized using frequency and percentage for all patients.
Measured: 4 weeks
Secondary outcomes (4)
Overall survival
Estimated using the Kaplan-Meier methods.
Measured: Up to 4 years
Disease-free survival
Estimated using the Kaplan-Meier methods.
Measured: Up to 4 years
Event-free survival
Estimated using the Kaplan-Meier methods.
Measured: Up to 4 years
Duration of complete remission
Complete remission rates will be estimated along with 95% credible intervals. Estimated using the Kaplan-Meier methods.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start31 Jan 2019
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tapan M Kadia, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530034
- Sponsor's protocol ID
- 2014-0057
- Other IDs
- NCI-2015-02131, P-TRP-2447-14, 2014-0057, P50CA100632, NCI-2015-02131
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2015
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02530034
- Acronym / sponsor ID
- 2014-0057
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Hu8F4) | Experimental | Drug: Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4Also: Hu8F4Given IV | Drug | Treatment (Hu8F4) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (Hu8F4) |
| Pharmacological StudyCorrelative studies | Other | Treatment (Hu8F4) |
Primary outcome
Minimum safety data
Time frame: 4 weeks
Safety data will be summarized using frequency and percentage for all patients.
Biologically-effective dose
Time frame: 4 weeks
Safety data will be summarized using frequency and percentage for all patients.
4 secondary outcomes
Overall survival
Time frame: Up to 4 years
Disease-free survival
Time frame: Up to 4 years
Event-free survival
Time frame: Up to 4 years
Duration of complete remission
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tapan M Kadia principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4, Laboratory Biomarker Analysis and Pharmacological Study in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum safety data (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.