Acute Myeloid LeukemiaPhase 1/2NCT02440568
AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients
A Phase 1/2 study testing Cytarabine, Idarubicin and Omacetaxine mepesuccinate in people with Acute Myeloid Leukemia, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytarabine, Idarubicin and Omacetaxine mepesuccinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2015to 30 Nov 2018
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, untreated patients with AML according to the WHO classification for AML. Prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m^2) for emergency use is also allowed as prior therapy.
- Patients age 18 to 70 years old who meet diagnostic criteria for AML according to the WHO classification for AML.
- Previously untreated AML (≥20% blasts). Note that prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- ECOG performance status of 0-3
- Adequate organ function, if not suspected to be due to AML, within 14 days of study registration, defined as:
- Total bilirubin ≤ 2.0 x ULN (unless due to hemolysis) AST and ALT ≤ 3 X ULN (unless believed to be due to tumor involvement) Serum Creatinine ≤ 1.5 x ULN Creatinine Clearance > 30 ml/min
- Negative urine or serum pregnancy test in females. Patients of reproductive potential (males and females) must consent to and practice double-barrier methods of contraception during treatment and for 12 weeks following the last dose of Omacetaxine. Adequate contraception is defined as double-barrier protection (i.e., condom plus spermicide in combination with a diaphragm, cervical/vault cap, or intrauterine device). Birth control pills, birth control patches and/or injections of hormones to prevent pregnancy are not considered an adequate method of preventing pregnancy, and double-barrier protection is required while on study and for 12 weeks after last dose. Patients will be instructed to notify the investigator if pregnancy is discovered either during or within 12 weeks of completing treatment with Omacetaxine. This also applies to male patients whose partners become pregnant while the patient is on study or within the 12 week period after the last dose of study drug.
- Patients must be willing and able to review, understand, and provide written consent before starting therapy.
Who cannot join
- Acute promyelocytic leukemia.
- Investigational drug within 4 weeks of study entry.
- Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- Female subjects who are pregnant or breast feeding.
- Patients who are HIV positive.
- Active uncontrolled infection or severe systemic infection (enrollment is possible after control of infection).
Show all 11Show fewer
- Concurrent malignancy (other than AML) with an estimated life expectancy less than two years and requiring active therapy.
- Psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up.
- Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or medically relevant active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Pregnant or breastfeeding: Omacetaxine is a Pregnancy Category D medication and has caused embryo-fetal death in animals. Confirmation that the subject is not pregnant must be established by a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard-of-Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
Read the detailed description
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML). Omacetaxine will be given subcutaneously Q12 hours on Days 1-7. The optimally safe and active dose (OD) will be determined using the EffTox design. EffTox is a Bayesian adaptive design that seeks to determine the optimal dose for further study in Phase II by considering a trade-off between efficacy and toxicity. The EffTox design begins by treating a cohort of three patients at dose level 1. These patients' efficacy and toxicity outcomes are used to update the posterior distributions for the probability of efficacy and toxicity and identify acceptable dose levels. The study terminates if no dose levels are acceptable. Otherwise, the acceptable doses are ranked using the Euclidean distance from (1.0, 0.0) and the next cohort is treated at the dose with the minimum distance under the restriction that we may only escalate or deescalate by one dose level at a time (e.g., the second cohort can only escalate to dose level 2 or deescalate to dose level -1). The second cohort is treated at the dose with the minimum distance and posterior distributions, and the list of acceptable doses and distances are updated as before. This process continues until at least 20 subjects are enrolled in the study. The dose with the minimum distance at study completion is considered the optimal dose for further investigation. If none of the dose levels are acceptable at study completion, an optimal dose level will not be identified and the drug does not warrant further investigation.
Post induction therapy will consist of standard cytarabine consolidation chemotherapy or allogeneic stem cell transplantation based on pretreatment risk assessment.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytarabine, Idarubicin, Omacetaxine mepesuccinate
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Also called Cytosine arabinoside, Ara-C, Cytosar
Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
IdarubicinDrug
Also called Idamycin PFS, Idamycin®
Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
Omacetaxine mepesuccinateDrug
Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m^2
Omacetaxine mepesuccinateDrug
Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m^2
Omacetaxine mepesuccinateDrug
Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m^2
Omacetaxine mepesuccinateDrug
Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2 | Experimental | Patients will receive Omacetaxine at Dose level 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Omacetaxine mepesuccinate |
| Cohort 2: Omacetaxine at Dose level at 1.25mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Omacetaxine mepesuccinate |
| Cohort 3: Omacetaxine at Dose level at 2.0mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Omacetaxine mepesuccinate |
| Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ | Experimental | Patients will receive Omacetaxine at Dose level 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Omacetaxine mepesuccinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimally Tolerated Dose
The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate.
OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction).
Measured: Within 50 days (duration of hematologic recovery)
Secondary outcomes (5)
Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading
Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading
Measured: Up to 6 months after last dose of Omacetaxine
Time to Hematologic Recovery
Time to Absolute Neutrophil Count > 1.0 x 10e9/L and Platelet Count > 100 x 10e9/L, whichever was later, for those patients who achieved a remission and achieved these hematologic goals.
Measured: Within 6 months of last dose of Omacetaxine
Overall Participant Survival
Observed overall survival among participants (days)
Measured: 3 years
Event Free Survival
Observed length of time (days) after which patients remained free of recurrence or death.
Measured: 6 months
Progression Free Survival
Among the participants who achieved CR,CRi, progression free survival in number of days, i.e. the number of days participants who achieved CR/CRi remained alive and in a remission.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start5 Jun 2015
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, John Quigley, University of Illinois Chicago
- Investigators
- John Quigley, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440568
- Sponsor's protocol ID
- 2015-0181
- Other IDs
- 2015-0181
- Status last verified
- Jul 2021
- First submitted
- 7 May 2015
- Last updated
- 6 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard-of-Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients
- ClinicalTrials.gov ID
- NCT02440568
- Acronym / sponsor ID
- 2015-0181
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 5 Jun 2015 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 6 Jul 2021
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 dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
Detailed description
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML). Omacetaxine will be given subcutaneously Q12 hours on Days 1-7. The optimally safe and active dose (OD) will be determined using the EffTox design. EffTox is a Bayesian adaptive design that seeks to determine the optimal dose for further study in Phase II by considering a trade-off between efficacy and toxicity. The EffTox design begins by treating a cohort of three patients at dose level 1. These patients' efficacy and toxicity outcomes are used to update the posterior distributions for the probability of efficacy and toxicity and identify acceptable dose levels. The study terminates if no dose levels are acceptable. Otherwise, the acceptable doses are ranked using the Euclidean distance from (1.0, 0.0) and the next cohort is treated at the dose with the minimum distance under the restriction that we may only escalate or deescalate by one dose level at a time (e.g., the second cohort can only escalate to dose level 2 or deescalate to dose level -1). The second cohort is treated at the dose with the minimum distance and posterior distributions, and the list of acceptable doses and distances are updated as before. This process continues until at least 20 subjects are enrolled in the study. The dose with the minimum distance at study completion is considered the optimal dose for further investigation. If none of the dose levels are acceptable at study completion, an optimal dose level will not be identified and the drug does not warrant further investigation.
Post induction therapy will consist of standard cytarabine consolidation chemotherapy or allogeneic stem cell transplantation based on pretreatment risk assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2 | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Omacetaxine mepesuccinatePatients will receive Omacetaxine at Dose level 0.625mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
| Cohort 2: Omacetaxine at Dose level at 1.25mg/m^ | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Omacetaxine mepesuccinatePatients will receive Omacetaxine at Dose level 1.25mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
| Cohort 3: Omacetaxine at Dose level at 2.0mg/m^ | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Omacetaxine mepesuccinatePatients will receive Omacetaxine at Dose level 2.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
| Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Omacetaxine mepesuccinatePatients will receive Omacetaxine at Dose level 3.0mg/m^2, Cytarabine and Idarubicin as part of the treatment plan. Study participants will follow in outpatient clinic at least every 2 months for a total of 6 months. A final study visit will occur 6 months (+/-1 week) after the last dose of Omacetaxine. This visit will end study participation unless there is ongoing toxicity that is at least possibly related to study treatment. In this case, the patient will be followed as medically appropriate until resolution or stabilization of the adverse event. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed, untreated patients with AML according to the WHO classification for AML. Prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m^2) for emergency use is also allowed as prior therapy.
- Patients age 18 to 70 years old who meet diagnostic criteria for AML according to the WHO classification for AML.
- Previously untreated AML (≥20% blasts). Note that prior short-term therapy (≤7 days) with hydroxyurea, steroids, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors, azacitidine, ATRA), or hematopoietic growth factors is allowed. A single or two-day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- ECOG performance status of 0-3
- Adequate organ function, if not suspected to be due to AML, within 14 days of study registration, defined as:
Key exclusion criteria (11 listed)
- Acute promyelocytic leukemia.
- Investigational drug within 4 weeks of study entry.
- Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- Female subjects who are pregnant or breast feeding.
- Patients who are HIV positive.
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 |
|---|---|---|
| CytarabineAlso: Cytosine arabinoside, Ara-C, CytosarCytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days. | Drug | Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2, Cohort 2: Omacetaxine at Dose level at 1.25mg/m^, Cohort 3: Omacetaxine at Dose level at 2.0mg/m^, Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ |
| IdarubicinAlso: Idamycin PFS, Idamycin®Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3. | Drug | Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2, Cohort 2: Omacetaxine at Dose level at 1.25mg/m^, Cohort 3: Omacetaxine at Dose level at 2.0mg/m^, Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ |
| Omacetaxine mepesuccinateOmacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m^2 | Drug | Cohort 1: Omacetaxine at Dose level at 0.625mg/m^2 |
| Omacetaxine mepesuccinateOmacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m^2 | Drug | Cohort 2: Omacetaxine at Dose level at 1.25mg/m^ |
| Omacetaxine mepesuccinateOmacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m^2 | Drug | Cohort 3: Omacetaxine at Dose level at 2.0mg/m^ |
| Omacetaxine mepesuccinateOmacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m^2 | Drug | Cohort 4: Omacetaxine at Dose level at 3.0mg/m^ |
Primary outcome
Optimally Tolerated Dose
Time frame: Within 50 days (duration of hematologic recovery)
The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate. OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction).
5 secondary outcomes
Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading
Time frame: Up to 6 months after last dose of Omacetaxine
Time to Hematologic Recovery
Time frame: Within 6 months of last dose of Omacetaxine
Overall Participant Survival
Time frame: 3 years
Event Free Survival
Time frame: 6 months
Progression Free Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John Quigley, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cytarabine, Idarubicin and Omacetaxine mepesuccinate in people with Acute Myeloid Leukemia, run by University of Illinois Chicago 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 8 inclusion and 11 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 6 Jul 2021. 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 combined 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.
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 6 Jul 2021). 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?
Optimally Tolerated Dose (time frame: Within 50 days (duration of hematologic recovery)). 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 6 Jul 2021.