HEMATOLOGIC MALIGNANCY

St. Joseph Health Medical Group is currently enrolling patients for the following hematology malignancy clinical trials:

Myelofibrosis and Essential Thrombocythemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Lymphoma
Multiple Myeloma

Myelofibrosis and Essential Thrombocythemia

Prospective, Longitudinal, Non-Interventional Study of Disease Burden and Treatment of Patients With Low-Risk Myelofibrosis (Mf) or High-Risk Essential Thrombocythemia (Et) or Et Patients Receiving Et-Directed Therapy (MOST)

Registry Study

The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia or myelofibrosis.

Treatment agent: N/A
PI: Jarrod Holmes, MD
Study Coordinator: Catherine Hollister // Catherine.Hollister@stjoe.org // (707) 521-3808
Resources and Links: clinicaltrials.gov NCT No: NCT02953704

Myelodysplastic Syndrome

A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia (JIT Takeda 3001)

Phase III

The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves overall response rate by Cycle 6 and whether the combination of pevonedistat and azacitidine improves event-free survival when compared with single-agent azacitidine.

Treatment agent: Pevonedistat
PI: Thomas Stanton, MD
Study Coordinator: Kim Young // Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links: clinicaltrials.gov NCT No: NCT03268954

A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent (JIT Onconova)

Phase III

The study's primary objective is to compare the overall survival of patients with MDS after failure of treatment with azacitidine or decitabine in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Treatment agent: Rigosertib (PLK1 inhibitor)
PI: Thomas Stanton, MD
Study Coordinator: Kim Young // Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links: clinicaltrials.gov NCT No: NCT02562443

A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB) (Fibrogen)

Phase III

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden. This study includes an Open-Label and a Double-Blind component.

Treatment agent: Roxadustat
PI: Jarrod Holmes, MD
Study Coordinator: Study Coordinator: Tracy Foster // Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links: clinicaltrials.gov NCT No: NCT03263091

Acute Myeloid Leukemia

The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry (Connect MDS/AML)

Registry Study

This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how newly diagnosed MDS, ICUS or AML patients are treated; and to build a knowledge base regarding the effectiveness and safety of front-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for MDS, ICUS or AML according to the standard of care and routine clinical practice at each study site.

Treatment agent: N/A
PI: Thomas Stanton, MD
Study Coordinator: Diego Martinez // Diego.Martinez@stjoe.org // (707) 521-3810
Resources and Links: clinicaltrials.gov NCT No: NCT01688011

Chronic Lymphocytic Leukemia

A Disease Registry for Patients with Chronic Lymphocytic Leukemia (InformCLL)

Registry Study

This study is a multicenter, prospective, observational registry of CLL patients designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL/SLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported Health related Quality of Life.

Treatment agent: N/A
PI: Wes Lee, MD
Study Coordinator: Diego Martinez // Diego.Martinez@stjoe.org // (707) 521-3810
Resources and Links: clinicaltrials.gov NCT No: NCT02761187

Lymphoma

Follicular Lymphoma
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Diffuse Large B-Cell Lymphoma

Follicular Lymphoma

A Phase 2, Multicenter, Open-Label, Randomized Study Comparing INCB050465, a PI3Kδ Inhibitor, to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL 203)

Phase II

The purpose of this study is to assess the objective response rate of INCB050465 treatment in subjects with relapsed or refractory follicular lymphoma.

Treatment agent: INCB050465 (PI3Kδ Inhibitor)

PI: Thomas Stanton, MD

Study Coordinator: Teresa Lund // Teresa.Lund@stjoe.org // (707) 521-3803

Resources and Links: clinicaltrials.gov NCT No: NCT03126019

Marginal Zone Lymphoma

A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL 204)

Phase II

The purpose of this study is to evaluate the safety and efficacy of two INCB050465 treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Treatment agent: INCB050465 (PI3Kδ Inhibitor)
PI: Thomas Stanton, MD
Study Coordinator: Teresa Lund // Teresa.Lund@stjoe.org // (707) 521-3803
Resources and Links: clinicaltrials.gov NCT No: NCT03144674

Mantle Cell Lymphoma

A Phase 2, Open-Label, Two-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL 205)

Phase II

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 INCB050465 treatment regimens in relapsed or refractory MCL previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Diffuse Large B-Cell Lymphoma

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects with Hematological Malignancies (JIT eFFECTOR)

Phase I-II

This clinical trial is a dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of eFT508, a mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2 inhibitor, in subjects with previously treated lymphomas, including non germinal-center B cell relapsed/ refractory DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), Burkitt/Burkitt-like lymphoma (BL/BLL), Hodgkin lymphoma (HL), or lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). The study will evaluate oral daily administration of eFT508.

Treatment agent: eFT508 (MNK1 & MNK2 inhibitor)
PI: Thomas Stanton, MD
Study Coordinator: Kim Young // Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links: clinicaltrials.gov NCT No: NCT02937675

Multiple Myeloma

A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (Millennium)

Phase II/III

The purpose of this study is to compare the effect of ixazomib + dexamethasone versus pomalidomide + dexamethasone on progression-free survival in participants with relapsed and/or refractory multiple myeloma who have received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor, and are refractory to lenalidomide but not refractory to proteasome inhibitors.

Treatment agent: Ixazomib
PI: Ian Anderson, MD
Study Coordinator: Teresa Lund // Teresa.Lund@stjoe.org // (707) 521-3803
Resources and Links: clinicaltrials.gov NCT No: NCT03170882

A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients (InsightMM)

Registry Study

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes surveys during on-site routine office visits.

Treatment agent: N/A
PI: Ian Anderson, MD
Study Coordinator: Diego Martinez // Diego.Martinez@stjoe.org // (707) 521-3810
Resources and Links: clinicaltrials.gov NCT No: NCT02761187