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: Jennafer Carlin Rosset //
Jennafer.Carlin@stjoe.org // (707) 521-3833
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
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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.
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: NCT03235544
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
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
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