Acute Myelogenous LeukemiaPhase 2NCT03059615
A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS
A Phase 2 study testing Nerofe and Doxorubicin in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Immune System Key Ltd at 2 sites in Israel.
Trial summary
This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles). Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Nerofe and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- 25 Oct 2018to 26 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Males and females ≥18 years of age.
- Either:
- AML patients, who are not candidates for aggressive therapy and/or stem cell transplant (usually the elderly patients), or
- Low and high prognostic risk MDS patients (according to the IPSS-R classification), resistant or relapsing following at least 1 course of hypo-methylation therapy.
- Anti-tumor (in this case the anti-MDS or anti-leukemic) effect can be measured according to the IWG criteria (Appendices B, C).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
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- Acceptable clinical laboratory values at screening, as indicated by:
- Absolute neutrophil count ≥ 1,000/mm3;
- Platelets ≥ 50,000/mm3;
- Hemoglobin ≥ 6.5 g/dl ;
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN);
- AST (SGOT) ≤ 2.5 × the ULN;
- ALT (SGPT) ≤ 2.5 × the ULN;
- Serum creatinine ≤ 1.5 mg/dL or a measured creatinine clearance 60 mL/min and above
- Negative serum β hCG test in women of childbearing potential
- Women of childbearing potential must agree to use dual contraceptive methods while on study drug and for 3 months afterward.
- Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods while on study drug and for 3 months afterward.
- Willing and able to provide written acceptance that during the trial, bone marrow examination should be performed, with cytogenetics. Bone marrow examination will be performed at Screening, Cycle 3, every odd subsequent cycles and End of Dosing Visit (as per PI and Medical Monitor decision).
- Bone marrow positive for ST2 receptor expression.
- Willing and able to provide written Informed Consent and comply with the requirements of the study
Who cannot join
- Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy 30 days prior to study entry and , immunosuppressive therapy, prednisone > 20 mg/day, or any equivalent corticosteroids during the last six months.
- Erythroid stimulating agents are allowed until one day prior to treatment initiation with study drug.
- Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 2, as determined by NCI CTCAE v 4.0
- Receipt of >1 prior regimen of genotoxic therapy.
- Previous bone marrow transplantation.
- Life expectancy <12 weeks.
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- RBC transfusions for at least 1 week and platelet transfusions for at least 3 days prior to study entry.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness (AIDS).
- Known active hepatitis B or C or other active liver disease
- Active infection requiring systemic therapy.
- Unstable Insulin-dependent diabetes mellitus (IDDM), defined by one or more hospitalization (including ER visits) due to high or low blood glucose levels within the last 6 months.
- History of any of the following within 12 months prior to initiation of study drug: Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), unstable angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism (within the last 6 month).
- Uncontrolled hypertension and change in treatment regimen within the last month prior to screening.
- Risk of syncope, in the judgment of the Principle Investigator, according to the patient's history of Syncope.
- History of ongoing cardiac dysrhythmias requiring drug treatment.
- Malignancies during the last yearexcept for skin non-melanomatous tumors and thyroid carcinomas..
- Any known severe multiple allergy or acute allergic reaction.
- Use of any investigational agents within 4 weeks or 5 half-lives of initiation of study drug.
- Pregnant or lactating women.
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.
- For combination therapy only:
- Impaired cardiac function defined as left ventricular ejection fraction (LVEF) ≤ 55 % as measured by ECHO.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rabin Medical Center
Petah Tikva, 4941492
Kaplan Medical Center
Rehovot, 76100
About this study
Official title: A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS
This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).
Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of the drug action.
Read the detailed description
Nerofe is a first-in-class hormone peptide with cancer suppressive properties. It works in three mechanisms of action. The purpose of this research is to study Nerofe's effect in patients diagnosed with AML and MDS.
- Being tested
- Nerofe, Doxorubicin
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerofeDrug
Nerofe is a first-in-class hormone-peptide with cancer suppressive properties. Nerofe is a derivative of the human hormone-peptide Tumor-Cells Apoptosis Factor (TCApF). It contains 14 amino-acids. Binding Nerofe to the T1/ST2 receptor caused a rapid activation both of Caspase 8 and Bcl-2 mediated downstream in proliferating cancer cells.
DoxorubicinDrug
Doxorubicin is an anthracycline antibiotic with antineoplastic activity. Doxorubicin, isolated from the bacterium Streptomyces peucetius var. caesius, is the hydroxylated congener of daunorubicin. Doxorubicin intercalates between base pairs in the DNA helix, thereby preventing DNA replication and ultimately inhibiting protein synthesis.
| Study group | Role | What they receive |
|---|---|---|
| Nerofe 48mg/m2 | Experimental | 48mg/m2 IV Nerofe - three times a week Receives: Drug: Nerofe |
| Nerofe 96mg/m2 | Experimental | 96mg/m2 IV Nerofe - three times a week Receives: Drug: Nerofe |
| Nerofe 48mg/m2 + Doxorubicin 10mg/m2 | Experimental | 48mg/m2 IV Nerofe + Doxorubicin 10mg/m2 - once a week Receives: Drug: Nerofe; Drug: Doxorubicin |
| Nerofe 96mg/m2 + Doxorubicin 10mg/m2 | Experimental | 96mg/m2 IV Nerofe + Doxorubicin 10mg/m2 - once a week Receives: Drug: Nerofe; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change in IWG Criteria to evaluate response to Nerofe treatment (with or without Doxorubicin) for AML subjects
Bone Marrow samples and CBC will be done every 2 cycles
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher the percentage the worse outcome).
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Complete Blood Count (CBC) to measure hemoglobin (g/dL). Range 4-20 (4 worse outcome and 20 best outcome).
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Complete Blood Count (CBC) to measure absolute neutrophil count (x10^9/L). Range 0-15 (the higher the score the better outcome).
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Complete Blood Count (CBC) to measure platelets (x10^9/L). Range 0-2000 (the higher the score the better outcome)
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Measuring cytogenetic abnormalities. Range from very good (0) to very poor (4)
Measured: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Safety as determined by frequency, nature and severity of adverse events
Per CTCAE v4.0
Measured: 13 months
Secondary outcomes (7)
Pharmacokinetic behavior of Nerofe: Maximum Plasma Concentration (Cmax)
Done at Cycle 1 and 2: pre-dose, 15 minutes, 1, 2, 4, 6, 8 and 24 hours.
Measured: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Minimum Plasma Concentration (Cmin)
Done at Cycle 1 and 2: pre-dose, 15 minutes, 1, 2, 4, 6, 8 and 24 hours.
Measured: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Area Under the Curve (AUC)
Done at Cycle 1 and 2: pre-dose, 15 minutes, 1, 2, 4, 6, 8 and 24 hours.
Measured: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Tmax
Done at Cycle 1 and 2: pre-dose, 15 minutes, 1, 2, 4, 6, 8 and 24 hours.
Measured: At cycles 1 and 2 (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in levels of circulating cytokines
At Cycle 1 and 2 on Day 1 and Day 15 and on day 1 of each consecutive cycle (up to 12 cycles)
Measured: Every cycle (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in levels of soluble T1/ST2 receptor
At Cycle 1 and 2 on Day 1 and Day 15 and on day 1 of each consecutive cycle (up to 12 cycles)
Measured: Every cycle (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in PBMCs' T1/ST2 receptor expression
At Cycle 1 and 2 on Day 1 and Day 15 and on day 1 of each consecutive cycle (up to 12 cycles)
Measured: Every cycle (Cycle length 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start25 Oct 2018
- Primary completion26 Jul 2020
- Study completion26 Jul 2020
Why it stopped: No recruitment since initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 2 stage study: 1. Dose Range Finder (4 treatment arms) 2. Dose Confirmation (1 chosen treatment arm)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune System Key Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Devary, Study director, Immune System Key Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059615
- Sponsor's protocol ID
- ISK-N102
- Status last verified
- Jul 2020
- First submitted
- 9 Feb 2017
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS
- ClinicalTrials.gov ID
- NCT03059615
- Acronym / sponsor ID
- ISK-N102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment since initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Immune System Key LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 26 Jul 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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 is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles).
Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of the drug action.
Detailed description
Nerofe is a first-in-class hormone peptide with cancer suppressive properties. It works in three mechanisms of action. The purpose of this research is to study Nerofe's effect in patients diagnosed with AML and MDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 stage study: 1. Dose Range Finder (4 treatment arms) 2. Dose Confirmation (1 chosen treatment arm)
| Arm | Type | Receives |
|---|---|---|
| Nerofe 48mg/m2 | Experimental | Drug: Nerofe48mg/m2 IV Nerofe - three times a week |
| Nerofe 96mg/m2 | Experimental | Drug: Nerofe96mg/m2 IV Nerofe - three times a week |
| Nerofe 48mg/m2 + Doxorubicin 10mg/m2 | Experimental | Drug: Nerofe, Drug: Doxorubicin48mg/m2 IV Nerofe + Doxorubicin 10mg/m2 - once a week |
| Nerofe 96mg/m2 + Doxorubicin 10mg/m2 | Experimental | Drug: Nerofe, Drug: Doxorubicin96mg/m2 IV Nerofe + Doxorubicin 10mg/m2 - once a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males and females ≥18 years of age.
- Either:
- Anti-tumor (in this case the anti-MDS or anti-leukemic) effect can be measured according to the IWG criteria (Appendices B, C).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Acceptable clinical laboratory values at screening, as indicated by:
Key exclusion criteria (22 listed)
- Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy 30 days prior to study entry and , immunosuppressive therapy, prednisone > 20 mg/day, or any equivalent corticosteroids during the last six months.
- Erythroid stimulating agents are allowed until one day prior to treatment initiation with study drug.
- Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 2, as determined by NCI CTCAE v 4.0
- Receipt of >1 prior regimen of genotoxic therapy.
- Previous bone marrow transplantation.
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 |
|---|---|---|
| NerofeNerofe is a first-in-class hormone-peptide with cancer suppressive properties. Nerofe is a derivative of the human hormone-peptide Tumor-Cells Apoptosis Factor (TCApF). It contains 14 amino-acids. Binding Nerofe to the T1/ST2 receptor caused a rapid activation both of Caspase 8 and Bcl-2 mediated downstream in proliferating cancer cells. | Drug | Nerofe 48mg/m2, Nerofe 48mg/m2 + Doxorubicin 10mg/m2, Nerofe 96mg/m2, Nerofe 96mg/m2 + Doxorubicin 10mg/m2 |
| DoxorubicinDoxorubicin is an anthracycline antibiotic with antineoplastic activity. Doxorubicin, isolated from the bacterium Streptomyces peucetius var. caesius, is the hydroxylated congener of daunorubicin. Doxorubicin intercalates between base pairs in the DNA helix, thereby preventing DNA replication and ultimately inhibiting protein synthesis. | Drug | Nerofe 48mg/m2 + Doxorubicin 10mg/m2, Nerofe 96mg/m2 + Doxorubicin 10mg/m2 |
Primary outcome
Assessing change in IWG Criteria to evaluate response to Nerofe treatment (with or without Doxorubicin) for AML subjects
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Bone Marrow samples and CBC will be done every 2 cycles
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher the percentage the worse outcome).
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Complete Blood Count (CBC) to measure hemoglobin (g/dL). Range 4-20 (4 worse outcome and 20 best outcome).
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Complete Blood Count (CBC) to measure absolute neutrophil count (x10^9/L). Range 0-15 (the higher the score the better outcome).
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Complete Blood Count (CBC) to measure platelets (x10^9/L). Range 0-2000 (the higher the score the better outcome)
Assessing changes in R-IPSS (Revised International Prognostic Scoring System) Score to evaluate response to Nerofe treatment (with or without Doxorubicin) for MDS patients. A calculation of several variables.
Time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)
Measuring cytogenetic abnormalities. Range from very good (0) to very poor (4)
Safety as determined by frequency, nature and severity of adverse events
Time frame: 13 months
Per CTCAE v4.0
7 secondary outcomes
Pharmacokinetic behavior of Nerofe: Maximum Plasma Concentration (Cmax)
Time frame: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Minimum Plasma Concentration (Cmin)
Time frame: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Area Under the Curve (AUC)
Time frame: At cycles 1 and 2 (Cycle length 28 days)
Pharmacokinetic behavior of Nerofe: Tmax
Time frame: At cycles 1 and 2 (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in levels of circulating cytokines
Time frame: Every cycle (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in levels of soluble T1/ST2 receptor
Time frame: Every cycle (Cycle length 28 days)
Pharmacodynamic analysis of changes from baseline in PBMCs' T1/ST2 receptor expression
Time frame: Every cycle (Cycle length 28 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Yoram Devary study director
Immune System Key Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nerofe and Doxorubicin in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by Immune System Key Ltd at 2 sites in Israel.
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 20 inclusion and 22 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: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessing change in IWG Criteria to evaluate response to Nerofe treatment (with or without Doxorubicin) for AML subjects (time frame: At end of Cycles 2, 4, 6, 8, 10, 12 (Cycle length 28 Days)). The study lists 7 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 31 Jul 2020.