Description:
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.
Title
- Brief Title: A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
- Official Title: A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Clinical Trial IDs
- ORG STUDY ID:
NLG2106
- NCT ID:
NCT02835729
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Idarubicin | | Phase 1a |
Cytarabine | | Phase 1a |
Indoximod Freebase | | Phase 1a |
Indoximod HCL F1 | | Phase 1b (CLOSED TO ACCRUAL) |
Indoximod HCL F2 | | Phase 1a |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - Idarubicin
- Cytarabine
- Indoximod Freebase
- 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. | - Idarubicin
- Cytarabine
- Indoximod HCL F1
|
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety assessed by development of RLT, AEs and laboratory parameters of indoximod. |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Phase 1 |
Secondary Outcome Measures
Measure: | Measurable Residual Disease Rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Clinical response rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Duration of complete response |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Event free survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Time on study to induction failure, relapse or death |
Measure: | Cumulative incidence of relapse (CIR) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Proportion of AML patients who become eligible for bone marrow transplantation |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Frequency and severity of adverse events |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetics: Serum concentrations (Cmax/Steady State) |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | NewLink Genetics Corporation |
Trial Keywords
Last Updated
June 4, 2020