Blood and Lymph Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Thrombocytopenia

Anemia

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Bone Marrow Diseases

Thrombocytosis

Thrombocythemia, Essential

Hematologic Diseases

Splenomegaly

Hemorrhagic Disorders

Blood Platelet Disorders

Cytopenia

Bone Marrow Neoplasms

Hematologic Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.

Pacritinib

Best Available Therapy

Simran Singh

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with thrombocytopenia and primary or secondary myelofibrosis. Approximately 300 eligible patients will be randomized in a 1:1:1 allocation to pacritinib 400 mg dosed QD, pacritinib 200 mg dosed BID, or BAT (includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.

Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia

A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT).

Proportion of patients achieving a ≥ 50% reduction in the total symptom score from baseline to Week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0). Responses (on a scale from 0 \[absent\] to 10 \[worst imaginable\]) to questions about symptoms (tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under the ribs on the left side) were used to calculate the TSS.

CTI BioPharma

All-Cause Mortality was assessed in the Total Randomized Population (n=311). Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (n=308).

Pacritinib, Once Daily

Pacritinib, Twice Daily

BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

New Zealand

Canada

Netherlands

Belgium

Hungary

United States

Czechia

United Kingdom

Australia

France

Germany

Russia

Region of Enrollment

Represents Intent To Treat population (number of randomized patients)

Beth Ziemba

BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)

Spleen Volume Reduction

Total Symptom Score (TSS) Reduction

Pacritinib, QD

Pacritinib, BID

Overall Study

Immune System Diseases

Lymphoma

Lymphoma, Mantle-Cell

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Hodgkin Lymphoma

SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

SB1518

Anas Younes, MD

Jonathan Friedberg, MD

Peter Martin, MD

Julie Vose, MD

Richard Klasa, MD

This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.

To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.

S*BIO

Chronic Graft Versus Host Disease

SB1518 taken orally daily for 28 consecutive days in a 28-day cycle

John Seymour, M.D.

Andrew Roberts, M.D.

Bik To, MD

Rami Komrokji, MD

Martha Wadleigh, MD

Ruben Mesa, MD

The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.

A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Chronic Disease

Disease Attributes

Myelodysplastic-Myeloproliferative Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Myelodysplastic/myeloproliferative Disease

Srdan Verstovsek, M.D, Ph.D

H. Joachim Deeg, M.D

Olatoyosi M. Odenike, M.D.

This study consists of two phases: the first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a Phase 2 study to define the efficacy and safety profile of single-agent SB1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (CIMF).

A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

SB1518 taken orally daily for 28 consecutive days in a 28 day cycle

Anas Younes, M.D.

This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.

A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia	NCT02055781	Primary Myelofi... Post-polycythem... Post-essential ...	Pacritinib Best Available ...	18 Years -	CTI BioPharma
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies	NCT01263899	Hodgkin Lymphom... Mantle Cell Lym... Indolent Lympho...	SB1518	18 Years -	S*BIO
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis	NCT00745550	Myelofibrosis Myeloproliferat... Polycythemia Ve... Essential Throm...	SB1518	18 Years -	S*BIO
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies	NCT00719836	Acute Myelogeno... Chronic Myeloge... Chronic Myelomo... Myelodysplastic... Myelofibrosis	SB1518	18 Years -	S*BIO
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies	NCT00719836	Acute Myelogeno... Chronic Myeloge... Chronic Myelomo... Myelodysplastic... Myelofibrosis	SB1518	18 Years -	S*BIO
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies	NCT01263899	Hodgkin Lymphom... Mantle Cell Lym... Indolent Lympho...	SB1518	18 Years -	S*BIO
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia	NCT02055781	Primary Myelofi... Post-polycythem... Post-essential ...	Pacritinib Best Available ...	18 Years -	CTI BioPharma
A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies	NCT00741871	Lymphoma, Malig... Hodgkin's Lymph... B Cell Lymphoma	SB1518	18 Years -	S*BIO

Spots Global Cancer Trial Database for sb1518

Every month we try and update this database with for sb1518 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sb1518

Every month we try and update this database with for sb1518 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sb1518 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.