Trials / Terminated

TerminatedNCT03146871

Recombinant EphB4-HSA Fusion Protein and Azacitidine or Decitabine for Relapsed or Refractory Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Patients Previously Treated With a Hypomethylating Agent

A Pilot/Safety Study of sEphB4-HSA in Combination With a Hypomethylating Agent (HMA) for Patients With Relapsed or Refractory Myelodysplastic Syndrome (MDS) and AML Previously Treated With a Hypomethylating Agent

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 7 (actual)

Sponsor: University of Southern California · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This trial studies the side effects of recombinant EphB4-HSA fusion protein when given together with azacitidine or decitabine in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia that has come back or has not responded to previous treatment with a hypomethylating agent. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypomethylating agents, such as azacitidine and decitabine, slow down genes that promote cell growth and can kill cells that are dividing rapidly. Giving recombinant EphB4-HSA fusion protein together with azacitidine or decitabine may work better in treating patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To describe the toxicities and assess the tolerability of recombinant EphB4-HSA fusion protein (sEphB4-HSA) in combination with an approved hypomethylating agent (HMA) among patients with myelodysplastic syndrome (MDS) who are refractory to or have lost their response to one or more HMAs and among patients with relapsed/refractory acute myeloid leukemia (AML) previously treated with a HMA. SECONDARY OBJECTIVES: I. To measure the expression of EphB4 among marrow and peripheral blood blasts in patients with MDS \& AML at baseline and over the course of treatment. II. To measure the expression of immune check-point activating ligands (such as PD-L1, PD-L2) on marrow and peripheral blood blasts in patients treated with HMA and sEphB4-HSA in combination. III. To profile immune subsets (activated and exhausted T cells, natural killer \[NK\] cells, T regulatory cells, and myeloid derived suppressor cells) in the peripheral blood and marrow in patients treated with HMA and sEphB4-HSA in combination. IV. To assess efficacy of sEphB4-HSA in combination with an HMA as manifest by International Working Group (IWG) response criteria, as well as time to development of acute myeloid leukemia (AML) in patients with MDS and time to progression. OUTLINE: Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1 and 15. Patients also receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9, or decitabine IV on days 1-5. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Conditions

Interventions

Type	Name	Description
DRUG	Azacitidine	Given IV or SC
DRUG	Decitabine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
BIOLOGICAL	Recombinant EphB4-HSA Fusion Protein	Given IV

Timeline

Start date: 2017-04-20
Primary completion: 2019-03-19
Completion: 2019-03-27
First posted: 2017-05-10
Last updated: 2019-04-18

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03146871. Inclusion in this directory is not an endorsement.