This phase III trial investigates the best dose of vinblastine in combination with
selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib
alone in treating children and young adults with low-grade glioma (a common type of brain
cancer) that has come back after prior treatment (recurrent) or does not respond to therapy
(progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells
grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill
cancer cells. Giving selumetinib in combination with vinblastine may work better than
selumetinib alone in treating recurrent or progressive low-grade glioma.

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Biospecimen Collection

Magnetic Resonance Imaging

Quality-of-Life Assessment

Questionnaire Administration

Selumetinib Sulfate

Vinblastine Sulfate

A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

This phase II trial studies how well the combination of dabrafenib and trametinib works after
radiation therapy in children and young adults with high grade glioma who have a genetic
change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells
and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells
by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their
growth. Giving dabrafenib with trametinib after radiation therapy may work better than
treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade
glioma.

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Dabrafenib Mesylate

Lumbar Puncture

Radiation Therapy

Trametinib Dimethyl Sulfoxide

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

The primary objective of this study is to evaluate the safety and efficacy of pitolisant
compared with placebo in treating excessive daytime sleepiness (EDS) in patients with
idiopathic hypersomnia (IH) age ≥18 years.
Key secondary objectives of this study are to assess the impact of pitolisant on:
-  Overall symptoms of IH
-  Patient impression of overall change in their symptoms of IH
-  Investigator assessment of overall disease severity of IH
Other secondary objectives of this study are to assess the impact of pitolisant in patients
with IH on:
-  Patient impression of overall severity of their EDS
-  Functional status and activities of daily living
-  Sleep-related impairment
-  Sleep inertia
-  Cognitive function

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Huntersville

ARSM Research

Pitolisant Oral Tablet

Placebo oral tablet

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus
placebo for the treatment of participants with active PsA who are naïve to biologic disease
modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long
term extension period will provide additional long-term safety and efficacy information.

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

OnSite Clinical Solutions

Deucravacitinib

Placebo

Apremilast

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell
responsible for fighting infections). The purpose of this study is to assess the safety and
tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants
with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be
assessed.
Epcoritamab is an investigational drug being developed for the treatment of NHL. Study
doctors put the participants in groups called treatment arms. The combination of epcoritamab
with anti-neoplastic agents will be explored. Each treatment arm receives a different
treatment combination depending on eligibility. Approximately 132 adult participants with NHL
will be enrolled in 100 sites globally.
In both the dose escalation and dose expansion arms participants will receive subcutaneous
(SC) epcoritamab in combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2
and 21- day cycles for arm 3.
Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with
relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in
participants with with R/R DLBCL.
Arm 3: SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab,
IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in
participants with newly diagnosed treatment-naïve DLBCL.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, questionnaires and side effects.

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Novant Health Presbyterian Medical Center /ID# 242148

Epcoritamab

Lenalidomide

Ibrutinib

Rituximab

Cyclophosphamide

Doxorubicin Hydrochloride [HCl]

Prednisone

Polatuzumab

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The
purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how
safe they are in adult participants with CLL who were previously treated with VenG. Adverse
events and change in disease activity will be assessed.
Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants
in 1 of 2 groups, called treatment arms, based on when symptoms of CLL came back after
previous treatment with VenG. Approximately 75 adult participants with CLL who have been
treated with VenG will be enrolled in the study in approximately 60 sites worldwide.
Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day
cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone,
for a total treatment of 12 to 24 cycles, depending on the cohort.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Novant Health Presbyterian Medical Center /ID# 230201

Venetoclax

Obinutuzumab

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

The purpose of this study is to test the long-term safety of rimegepant in the acute
treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of
age).

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Mecklenburg Neurology Group

Rimegepant / BHV3000

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age.

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in
the acute treatment of moderate or severe migraine in children and adolescents.

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

OnSite Clinical Solutions LLC

Rimegepant/BHV3000

Matching placebo

Phase 3, Multicenter, Randomized, Double-blind,Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant or the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age

This study will evaluate de-identified (anonymous) data in subject medical charts to review
the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Patient Retrospective Outcomes (PRO)

Carolinas Research Institute, PLLC

Non Boston Scientific Systems

Boston Scientific Systems

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Levine Children's Hospital

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

Charlotte, North Carolina

Charlotte

< 0 mi

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

< 0 mi

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

< 15 mi

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

< 0 mi

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

< 0 mi

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

< 0 mi

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

< 0 mi

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

< 0 mi

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

< 15 mi

Patient Retrospective Outcomes (PRO)

< 0 mi

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)