Acute Myelogenous Leukemia (AML)Phase 2NCT01873495

Omacetaxine for Consolidation and Maintenance

A Phase 2 study testing Omacetaxine in people with Acute Myelogenous Leukemia (AML), run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of… Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Acute Myelogenous Leukemia (AML)
What is being tested?: Omacetaxine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: May 2013to Jul 2018
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
Age ≥ 55 years.
Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
Provide signed written informed consent.
Be able to comply with study procedures and follow-up examinations.

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Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
Adequate renal and hepatic function at the time of second registration:
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
Serum creatinine ≤ 1.2 x ULN.
ECOG performance ≤ 2 at the time of second registration.
Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.

Who cannot join

Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha [RARa] and variants).
Prior treatment with omacetaxine.
Relapsed or refractory AML.
Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
Psychiatric disorders that would interfere with consent, study participation, or follow-up.
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
Active carcinoma requiring systemic chemotherapy or radiation therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study

Conditions: Acute Myelogenous Leukemia (AML)
Being tested: Omacetaxine
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.

OmacetaxineDrug
Also called Synribo
Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.
Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles

Study groups in NCT01873495
Study group	Role	What they receive
Omacetaxine: Consolidation/Maintenance	Experimental	Not described Receives: Drug: Omacetaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Status Assessment Prior to Each Consolidation Cycle
Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).
Measured: 14 days
Assessment of Disease Status
Bone marrow biopsy and aspirate will be obtained.
Measured: 1 month
Bone Marrow Aspirate to Confirm Continuous Remission
Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.
Measured: 3 months
Maintenance Toxicities
Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.
Measured: 24 weeks

Secondary outcomes (1)

Consolidation Toxicities
Toxicities will be monitored by history, physical examination, and laboratory monitoring (CBC, serum chemistries to include renal and liver function tests) obtained weekly during consolidation and monthly during maintenance according to standard of care (Appendices C and D). Toxicity will be assessed according to the NCI Common Toxicity Criteria Version 4.0 (available at the NCI web site http://ctep.cancer.gov/reporting/ctc.html).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jul 2018

First posted10 Jun 2013 (estimated)
Study startMay 2013
Primary completionJul 2018
Study completionJul 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 Myelogenous Leukemia (AML)Studies of the same condition, open and under way.
More trials run by Emory UniversityThe 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01873495
Sponsor's protocol ID: IRB00057844
Other IDs: Winship2176-11
Status last verified: Sep 2019
First submitted: 4 Jun 2013
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
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Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
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RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
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RecruitingPhase 2
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
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All Acute Myelogenous Leukemia (AML) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study
ClinicalTrials.gov ID: NCT01873495
Acronym / sponsor ID: IRB00057844
Conditions: Acute Myelogenous Leukemia (AML)
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 7 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Teva Pharmaceuticals USA
Study start: May 2013
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 10 Jun 2013 (estimated)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Omacetaxine: Consolidation/Maintenance	Experimental	Drug: Omacetaxine

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
Age ≥ 55 years.
Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
Provide signed written informed consent.

Key exclusion criteria (8 listed)

Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha [RARa] and variants).
Prior treatment with omacetaxine.
Relapsed or refractory AML.
Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
Psychiatric disorders that would interfere with consent, study participation, or follow-up.

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
OmacetaxineAlso: SynriboOmacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles. Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles	Drug	Omacetaxine: Consolidation/Maintenance

Primary outcome

Disease Status Assessment Prior to Each Consolidation Cycle
Time frame: 14 days
Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).
Assessment of Disease Status
Time frame: 1 month
Bone marrow biopsy and aspirate will be obtained.
Bone Marrow Aspirate to Confirm Continuous Remission
Time frame: 3 months
Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.
Maintenance Toxicities
Time frame: 24 weeks
Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.

1 secondary outcome

Consolidation Toxicities
Time frame: 12 weeks

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omacetaxine: Consolidation/Maintenance	7	0

Primary outcome: Disease Status Assessment Prior to Each Consolidation Cycle

Time frame: 14 days. Count of participants. Unit: Participants

Measure	Omacetaxine: Consolidation/Maintenance n = 7
Relapsed AML	0
Remission	7

Primary outcome: Assessment of Disease Status

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Omacetaxine: Consolidation/Maintenance n = 7
Relapsed AML	1
Remission	6

Population analysed: Seven patients completed at least one cycle of omacetaxine.

Primary outcome: Bone Marrow Aspirate to Confirm Continuous Remission

Time frame: 3 months

Population analysed: No patients entered the maintenance phase of this study.

Primary outcome: Maintenance Toxicities

Time frame: 24 weeks

Population analysed: No patients entered the maintenance phase of this study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected weekly during consolidation and monthly during maintenance.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omacetaxine: Consolidation/Maintenance	1 of 7 (14.3%)	1 of 7 (14.3%)	0 of 7

Limitations and caveats (from the sponsor): Accrual was halted early due to the inability of 30% of subjects to complete the intended consolidation and maintenance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Myelogenous Leukemia (AML)

Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
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RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
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Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
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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.

Martha L. Arellano, MD principal investigator

Emory University

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 Omacetaxine in people with Acute Myelogenous Leukemia (AML), run by Emory University 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 13 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: stopped early, as of the sponsor's last update on 24 Sep 2019. 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 24 Sep 2019). 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?

Disease Status Assessment Prior to Each Consolidation Cycle (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873495.

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 24 Sep 2019.