Acute Myeloid LeukemiaPhase 1NCT02835729
A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 study testing Idarubicin, Cytarabine and Indoximod Freebase in people with Acute Myeloid Leukemia, run by NewLink Genetics Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Idarubicin, Cytarabine and Indoximod Freebase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to 27 Dec 2019
- Phase
- Phase 1
- 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
- A histologically or pathologically confirmed diagnosis of AML based on WHO classification with or without extramedullary disease except for central nervous system disease.
- ECOG performance status ≤ 2
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Female patients of childbearing potential must have a negative pregnancy test < 1 week prior to enrollment.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patients receiving any other investigational agents or immunotherapy
- Patients who have received prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed
- Previous allo-HSCT of any kind
- Active, uncontrolled infection including known hepatitis B or C
- Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
- History of any other active cancer diagnosis
- Pregnant women
- Known HIV-infected patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Augusta University
Augusta, Georgia, 30912
University of Maryland
Baltimore, Maryland, 21201
About this study
Official title: A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Idarubicin, Cytarabine, Indoximod Freebase, Indoximod HCL F1, Indoximod HCL F2
- Keywords
- AML
- 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.
IdarubicinDrug
Chemotherapy
CytarabineDrug
Chemotherapy
Indoximod FreebaseDrug
IDO pathway inhibitor
Indoximod HCL F1Drug
IDO pathway inhibitor
Indoximod HCL F2Drug
IDO pathway inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a | Experimental | Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (freebase formulation). These patients will additionally receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels.
All current subjects will transition from indoximod freebase capsules over to indoximod HCL F2 tablets. All new subjects enrolled will also receive indoximod HCL F2 tablets. Receives: Drug: Idarubicin; Drug: Cytarabine; Drug: Indoximod Freebase; Drug: Indoximod HCL F2 |
| Phase 1b (CLOSED TO ACCRUAL) | Experimental | Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (HCL F1 formulation). These patients will receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels. Receives: Drug: Idarubicin; Drug: Cytarabine; Drug: Indoximod HCL F1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by development of RLT, AEs and laboratory parameters of indoximod.
Phase 1
Measured: 6 months
Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation.
Phase 1
Measured: 6 months
Secondary outcomes (9)
Measurable Residual Disease Rate
Measured: 2 years
Clinical response rate
Measured: 2 years
Duration of complete response
Measured: 2 years
Event free survival
Time on study to induction failure, relapse or death
Measured: 2 years
Cumulative incidence of relapse (CIR)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Proportion of AML patients who become eligible for bone marrow transplantation
Measured: 2 years
Frequency and severity of adverse events
Measured: 2 years
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion25 Oct 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835729
- Sponsor's protocol ID
- NLG2106
- Status last verified
- Jun 2020
- First submitted
- 11 Jul 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT02835729
- Acronym / sponsor ID
- NLG2106
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a | Experimental | Drug: Idarubicin, Drug: Cytarabine, Drug: Indoximod Freebase, Drug: Indoximod HCL F2Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (freebase formulation). These patients will additionally receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels. All current subjects will transition from indoximod freebase capsules over to indoximod HCL F2 tablets. All new subjects enrolled will also receive indoximod HCL F2 tablets. |
| Phase 1b (CLOSED TO ACCRUAL) | Experimental | Drug: Idarubicin, Drug: Cytarabine, Drug: Indoximod HCL F1Patients enrolled in this arm will receive standard induction and consolidation chemotherapy (7+3) with Indoximod (HCL F1 formulation). These patients will receive maintenance therapy with indoximod for 6 months after consolidation therapy. The indoximod dose will be studied in up to 4 dose levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A histologically or pathologically confirmed diagnosis of AML based on WHO classification with or without extramedullary disease except for central nervous system disease.
- ECOG performance status ≤ 2
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Female patients of childbearing potential must have a negative pregnancy test < 1 week prior to enrollment.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (8 listed)
- Patients receiving any other investigational agents or immunotherapy
- Patients who have received prior chemotherapy for AML with the exception of hydroxyurea or leukapheresis for leukocytosis; prior hypomethylating or immunomodulatory agents for MDS are allowed
- Previous allo-HSCT of any kind
- Active, uncontrolled infection including known hepatitis B or C
- Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
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 |
|---|---|---|
| IdarubicinChemotherapy | Drug | Phase 1a, Phase 1b (CLOSED TO ACCRUAL) |
| CytarabineChemotherapy | Drug | Phase 1a, Phase 1b (CLOSED TO ACCRUAL) |
| Indoximod FreebaseIDO pathway inhibitor | Drug | Phase 1a |
| Indoximod HCL F1IDO pathway inhibitor | Drug | Phase 1b (CLOSED TO ACCRUAL) |
| Indoximod HCL F2IDO pathway inhibitor | Drug | Phase 1a |
Primary outcome
Safety assessed by development of RLT, AEs and laboratory parameters of indoximod.
Time frame: 6 months
Phase 1
Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation.
Time frame: 6 months
Phase 1
9 secondary outcomes
Measurable Residual Disease Rate
Time frame: 2 years
Clinical response rate
Time frame: 2 years
Duration of complete response
Time frame: 2 years
Event free survival
Time frame: 2 years
Cumulative incidence of relapse (CIR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Proportion of AML patients who become eligible for bone marrow transplantation
Time frame: 2 years
Frequency and severity of adverse events
Time frame: 2 years
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Idarubicin, Cytarabine and Indoximod Freebase in people with Acute Myeloid Leukemia, run by NewLink Genetics Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 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: finished, as of the sponsor's last update on 4 Jun 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessed by development of RLT, AEs and laboratory parameters of indoximod. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.