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Clinical Trial

Wellness App for Sleep Disturbance in Hematological Cancer Patients

This trial aims to study the effectiveness of two different wellness-based mobile apps on blood cancer patient outcomes, including sleep, fatigue, anxiety, depression, and blood biomarkers of inflammation (TNF-a, IL-6, IL-8, CRP). The findings of this study may help physicians and researchers better understand how mobile wellness mobile apps can help in managing symptom burden and inflammation in blood cancer patients.

Clinical Trial

Consumer-Based Meditation App, Calm, for Treatment of Sleep Disturbance in Hematological Cancer Patients (CTMS# 22-0116)

Are you undergoing treatment for a blood cancer diagnosis and experiencing poor sleep?Researchers at the Mays Cancer Center are seeking US-based adults diagnosed with blood cancer and experiencing sleep disturbance to participate in a 20-week remote study testing a digital wellness intervention. Participants in this study will be assigned to use one of two digital wellness apps 10 minutes per day over 8-weeks to determine if it can help improve sleep, immune function, and other psychological and emotional outcomes.This study is completely remote (there are no in-person visits with the research team) and patients from across the USA are invited.Participation involves:One brief 30-minute virtual meeting with a research assistantCompleting online surveysProviding three blood samples over the 20-week study at a lab close to youTracking sleep using a small device and daily diaryUsing a wellness app for 10 minutes per day for 8-weeksParticipants who qualify and are enrolled in the study will be compensated at regular intervals, up to $100 total.

Clinical Trial

An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (CTMS# 18-0071)

This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)

Clinical Trial

A Multicenter Phase 1 Study to Determine the Maximum Tolerated Dose/ Maximum Feasible Dose, Safety, and Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered via Intraventricular Catheter for Leptomeningeal Metastases (CTMS# 21-0138)

This is an open-label, multicenter, Phase 1 dose-escalation study to establish the safety and tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) and to identify a maximum tolerated dose (MTD) and/or maximum feasible dose (MFD).

Clinical Trial

A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma (CTMS# 19-0069)

Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.

Clinical Trial

A Pilot Study to Evaluate the Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal cancer (CRC) Patients with Curative Resections.

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Clinical Trial

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and
Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab
in Patients With Previously Untreated, Locally Advanced Inoperable or
Metastatic Triple-Negative Breast Cancer, W

This is an international, multicenter, open-label, randomized, Phase 3 study in patients with locally advanced, inoperable, or metastatic triple-negative breast cancer (mTNBC) who have not received previous therapy for advanced disease and whose tumors are PD-L1 positive (defined using the PD-L1 IHC 22C3 assay as tumors with a combined positive score [CPS] ≥ 10) at screening.

Clinical Trial

postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a

postMONARCH is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlledstudy in participants with HR+, HER2- advanced or metastatic breast cancer. This study willenroll adults who experienced disease progression on a CDK4 & 6 inhibitor and an AI in thefirst-line setting or relapse on/after a CDK4 & 6 inhibitor with ET in the adjuvant setting.