Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 2NCT03146871
Recombinant EphB4-HSA Fusion Protein and Azacitidine or Decitabine for Relapsed or Refractory Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Patients Previously Treated With a Hypomethylating Agent
A Phase 2 study testing Azacitidine, Decitabine and Laboratory Biomarker Analysis in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, run by University of Southern California at 1 site in United States.
Trial summary
This trial studies the side effects of recombinant EphB4-HSA fusion protein when given together with azacitidine or decitabine in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not responded to previous treatment with a… 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, Chronic Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndrome
- What is being tested?
- Azacitidine, Decitabine and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 27 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult subjects with advanced MDS requiring treatment with HMA and either refractory to at least 4 cycles or progressing after previously documented response
- Patient must be treated within 6 months of the last HMA treatment and must be willing to be treated with the same agent they last received on this study
- Prior treatment with novel HMA analog of decitabine on clinical trial is allowed; in such cases, decitabine will be used as the standard of care agent
- MDS classified as intermediate 1-risk or high risk according to the international prognostic scoring system (IPSS) or revised-IPSS
- Chronic myelomonocytic leukemia (CMML)
- Acute myeloblastic leukemia (AML) that was previously treated with HMA and is unfit for intensive chemotherapy
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- Patient must be within 6 months of prior treatment with HMA and must be willing to be treated with the same agent on this study
- During the 8 weeks prior to inclusion in study, subjects must have a baseline bone marrow examination including all of the following:
- Cytomorphology to confirm bone marrow blasts
- Cytogenetics
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Subject is able to understand and willing to comply with protocol requirements and instructions
- Subject has signed and dated informed consent
- Total bilirubin (except for Gilbert's syndrome) =< 2.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
- Creatinine =< 2.5 x ULN
- Women of childbearing potential (WOCBP) and male patients with WOCBP as partners must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of the investigational agent; subject is practicing an acceptable method of contraception (documented in case report form [CRF]); WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:
- Amenorrhea >= 12 consecutive months without another cause or
- For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
- Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
- WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
- Patients with uncontrolled hypertension
Who cannot join
- Patients with AML whose white blood cell count exceeds 25,000
- Corrected QT (QTc) (Fridericia Correction Formula) > 480 on electrocardiogram (ECG)
- Patients whose electrolytes (sodium, potassium, calcium, magnesium) are abnormal or cannot be normalized with standard intervention on the day of treatment with study drug
- Patients who are actively receiving any other anticancer therapy
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to HMAs
- Patients with a diagnosis of acute promyelocytic leukemia
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- Patients with short life expectancy (less than 3 months) due to comorbidity other than MDS
- Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test)
- Patients with current alcohol or drug abuse
- Patients who have received treatment with an investigational drug within 30 days preceding the first dose of study medication
- Patients with uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients infected with hepatitis B, C or human immunodeficiency virus (HIV), unless they are on stable and effective antiviral treatment
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization; inhaled or topical steroids and adrenal replacement steroid doses > 10mg daily prednisone equivalent, are permitted in the absence of uncontrolled autoimmune disease
- MEDICATION-RELATED EXCLUSION CRITERIA
- Patients with uncontrolled hypertension (HTN) (> 160/90) will not be admitted onto the study
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot/Safety Study of sEphB4-HSA in Combination With a Hypomethylating Agent (HMA) for Patients With Relapsed or Refractory Myelodysplastic Syndrome (MDS) and AML Previously Treated With a Hypomethylating Agent
This trial studies the side effects of recombinant EphB4-HSA fusion protein when given together with azacitidine or decitabine in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not responded to previous treatment with a hypomethylating agent. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypomethylating agents, such as azacitidine and decitabine, slow down genes that promote cell growth and can kill cells that are dividing rapidly. Giving recombinant EphB4-HSA fusion protein together with azacitidine or decitabine may work better in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Read the detailed description
PRIMARY OBJECTIVES:
- To describe the toxicities and assess the tolerability of recombinant EphB4-HSA fusion protein (sEphB4-HSA) in combination with an approved hypomethylating agent (HMA) among patients with myelodysplastic syndrome (MDS) who are refractory to or have lost their response to one or more HMAs and among patients with relapsed/refractory acute myeloid leukemia (AML) previously treated with a HMA.
SECONDARY OBJECTIVES:
- To measure the expression of EphB4 among marrow and peripheral blood blasts in patients with MDS \& AML at baseline and over the course of treatment.
II. To measure the expression of immune check-point activating ligands (such as PD-L1, PD-L2) on marrow and peripheral blood blasts in patients treated with HMA and sEphB4-HSA in combination.
III. To profile immune subsets (activated and exhausted T cells, natural killer [NK] cells, T regulatory cells, and myeloid derived suppressor cells) in the peripheral blood and marrow in patients treated with HMA and sEphB4-HSA in combination.
IV. To assess efficacy of sEphB4-HSA in combination with an HMA as manifest by International Working Group (IWG) response criteria, as well as time to development of acute myeloid leukemia (AML) in patients with MDS and time to progression.
OUTLINE:
Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1 and 15. Patients also receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9, or decitabine IV on days 1-5. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
- Conditions
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Recurrent Adult Acute Myeloid Leukemia
- Being tested
- Azacitidine, Decitabine, Laboratory Biomarker Analysis, Pharmacological Study, Recombinant EphB4-HSA Fusion Protein
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC
Given IV or SC
DecitabineDrug
Also called 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Recombinant EphB4-HSA Fusion ProteinBiological
Also called sEphB4-HSA
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (sEphB4-HSA, azacitidine, decitabine) | Experimental | Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes at a dose of 15mg/kg on days 1 and 15 of a 28-day cycle. Patients also receive azacitidine IV or subcutaneously (SC) at a dose of 75mg/m2 on days 1-7 or days 1-5 and 8-9 on a 28-day cycle, or decitabine IV at a dose of 20 mg/m2 on days 1-5 on a 28-day cycle. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Azacitidine; Drug: Decitabine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Biological: Recombinant EphB4-HSA Fusion Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Toxicity to Hypomethylating Agent (HMA)
Toxicity will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, after each cycle.
Measured: Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Responses assessed by the International Working Group (IWG) 2023 criteria are a set of standardized guidelines used to assess treatment response in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). These criteria are designed to evaluate a patient's response based on hematologic improvements, such as changes in blood counts and transfusion independence.
Measured: Up to 56 days (2 courses of protocol treatment)
Time to Death From Any Cause
Will be displayed with Kaplan-Meier plots.
Measured: up to 1 year (12 cycles)
Time to Disease Progression
This will be measured from the start of treatment to the first disease progression or recurrence. Patients who are progression free at the time of last follow-up will be censored; death prior to progression will be counted as an event.
Measured: up to 1 year (12 cycles)
Tolerability Defined as the Ability to Complete Two Courses of Treatment Without the Occurrence of Dose Limiting Toxicity and the Ability to Begin Course 3 Within 4 Weeks and Graded According to the NCI CTCAE v4.0
Will be tabulated and reported according to grade, type, cycle, and attribution.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start20 Apr 2017
- Primary completion19 Mar 2019
- Study completion27 Mar 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Casey O'Connell, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146871
- Sponsor's protocol ID
- 9L-16-6
- Other IDs
- NCI-2017-00623, 9L-16-6, P30CA014089
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2017
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot/Safety Study of sEphB4-HSA in Combination With a Hypomethylating Agent (HMA) for Patients With Relapsed or Refractory Myelodysplastic Syndrome (MDS) and AML Previously Treated With a Hypomethylating Agent
- ClinicalTrials.gov ID
- NCT03146871
- Acronym / sponsor ID
- 9L-16-6
- Conditions
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Recurrent Adult Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the side effects of recombinant EphB4-HSA fusion protein when given together with azacitidine or decitabine in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not responded to previous treatment with a hypomethylating agent. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypomethylating agents, such as azacitidine and decitabine, slow down genes that promote cell growth and can kill cells that are dividing rapidly. Giving recombinant EphB4-HSA fusion protein together with azacitidine or decitabine may work better in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Detailed description
PRIMARY OBJECTIVES:
- To describe the toxicities and assess the tolerability of recombinant EphB4-HSA fusion protein (sEphB4-HSA) in combination with an approved hypomethylating agent (HMA) among patients with myelodysplastic syndrome (MDS) who are refractory to or have lost their response to one or more HMAs and among patients with relapsed/refractory acute myeloid leukemia (AML) previously treated with a HMA.
SECONDARY OBJECTIVES:
- To measure the expression of EphB4 among marrow and peripheral blood blasts in patients with MDS \& AML at baseline and over the course of treatment.
II. To measure the expression of immune check-point activating ligands (such as PD-L1, PD-L2) on marrow and peripheral blood blasts in patients treated with HMA and sEphB4-HSA in combination.
III. To profile immune subsets (activated and exhausted T cells, natural killer [NK] cells, T regulatory cells, and myeloid derived suppressor cells) in the peripheral blood and marrow in patients treated with HMA and sEphB4-HSA in combination.
IV. To assess efficacy of sEphB4-HSA in combination with an HMA as manifest by International Working Group (IWG) response criteria, as well as time to development of acute myeloid leukemia (AML) in patients with MDS and time to progression.
OUTLINE:
Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1 and 15. Patients also receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9, or decitabine IV on days 1-5. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (sEphB4-HSA, azacitidine, decitabine) | Experimental | Drug: Azacitidine, Drug: Decitabine, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Biological: Recombinant EphB4-HSA Fusion ProteinPatients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes at a dose of 15mg/kg on days 1 and 15 of a 28-day cycle. Patients also receive azacitidine IV or subcutaneously (SC) at a dose of 75mg/m2 on days 1-7 or days 1-5 and 8-9 on a 28-day cycle, or decitabine IV at a dose of 20 mg/m2 on days 1-5 on a 28-day cycle. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses 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 (22 listed)
- Adult subjects with advanced MDS requiring treatment with HMA and either refractory to at least 4 cycles or progressing after previously documented response
- MDS classified as intermediate 1-risk or high risk according to the international prognostic scoring system (IPSS) or revised-IPSS
- Chronic myelomonocytic leukemia (CMML)
- Acute myeloblastic leukemia (AML) that was previously treated with HMA and is unfit for intensive chemotherapy
- During the 8 weeks prior to inclusion in study, subjects must have a baseline bone marrow examination including all of the following:
Key exclusion criteria (15 listed)
- Patients with AML whose white blood cell count exceeds 25,000
- Corrected QT (QTc) (Fridericia Correction Formula) > 480 on electrocardiogram (ECG)
- Patients whose electrolytes (sodium, potassium, calcium, magnesium) are abnormal or cannot be normalized with standard intervention on the day of treatment with study drug
- Patients who are actively receiving any other anticancer therapy
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to HMAs
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 |
|---|---|---|
| AzacitidineAlso: 5 AZC, 5-AC, 5-Azacytidine, 5-AZCGiven IV or SC | Drug | Treatment (sEphB4-HSA, azacitidine, decitabine) |
| DecitabineAlso: 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, DeoxyazacytidineGiven IV | Drug | Treatment (sEphB4-HSA, azacitidine, decitabine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (sEphB4-HSA, azacitidine, decitabine) |
| Pharmacological StudyCorrelative studies | Other | Treatment (sEphB4-HSA, azacitidine, decitabine) |
| Recombinant EphB4-HSA Fusion ProteinAlso: sEphB4-HSAGiven IV | Biological | Treatment (sEphB4-HSA, azacitidine, decitabine) |
Primary outcome
Assessment of Toxicity to Hypomethylating Agent (HMA)
Time frame: Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
Toxicity will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, after each cycle.
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Time frame: Up to 56 days (2 courses of protocol treatment)
Responses assessed by the International Working Group (IWG) 2023 criteria are a set of standardized guidelines used to assess treatment response in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). These criteria are designed to evaluate a patient's response based on hematologic improvements, such as changes in blood counts and transfusion independence.
Time to Death From Any Cause
Time frame: up to 1 year (12 cycles)
Will be displayed with Kaplan-Meier plots.
Time to Disease Progression
Time frame: up to 1 year (12 cycles)
This will be measured from the start of treatment to the first disease progression or recurrence. Patients who are progression free at the time of last follow-up will be censored; death prior to progression will be counted as an event.
Tolerability Defined as the Ability to Complete Two Courses of Treatment Without the Occurrence of Dose Limiting Toxicity and the Ability to Begin Course 3 Within 4 Weeks and Graded According to the NCI CTCAE v4.0
Time frame: Up to 3 months
Will be tabulated and reported according to grade, type, cycle, and attribution.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Casey O'Connell, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Decitabine and Laboratory Biomarker Analysis in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, run by University of Southern California at 1 site 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 22 inclusion and 15 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: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Toxicity to Hypomethylating Agent (HMA) (time frame: Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.). The study lists 5 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 8 Jun 2026.