Hematología

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now

   Rochester, Minn.

   REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables.

   The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date.

   The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.

2. A Study to Evaluate Immune and Hematopoietic Cell Assessment in Clonal B Cell Conditions

   Rochester, Minn.

   The purpose of this study is to evaluate the immune and hematopoietic compartments in patients with monoclonal B cell lymphocytosis (MBL) and chronic lymphocytic leukemia (CLL) in comparison to age-matched healthy control (HC) donors.

3. Tissue and Blood Registry for Individuals with Liver and Biliary Tumors

   Jacksonville, Fla.

   This study will collect and store samples of tissue and blood for current and future research studies on Liver and Biliary Tumors.

4. A Study to Evaluate Maximizing Anti-PD-1 Therapy By Monitoring T Cell Responses In Melanoma, Lung and Other Cancer Types

   Rochester, Minn.

   The purpose of this study is to monitor T cell responses from patients with advanced cancer who are being treated with an anti-PD (programmed death)-1 monoclonal antibody, and compare them with clinical outcomes.

5. Alternate Doses and Dosing Schedules of Belantamab Mafodotin for the Treatment of Triple-Class Recurrent and/or Refractory Multiple Myeloma

   Jacksonville, Fla.

   The purpose of this study is to assess the 24-week grade 3/4 keratopathy-free rate of an alternative dose/dosing schedule for belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (RRMM).

    

6. A Study Evaluating the Safety and Effectiveness of JCAR017 to Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to determine the effectiveness and safety of JCAR017 in adult subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the effectiveness and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

7. Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

   Rochester, Minn.

   99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.

8. Hypo-fractionated Proton Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

9. Cell, Serum, and Buccal Bank for Patients with Chronic Myeloid Disorders and Acute Leukemia

   Rochester, Minn.

   This study is being done to store blood, buccal (cheek) cells, genetic material including DNA (deoxyribonucleic acid) and RNA (ribonucleic acid), and bone marrow so that they can be used for laboratory studies that may contribute to finding the causes of disease and factors that may determine disease progression and treatment response.

10. A Study of Healthy Donor Volunteers to Provide Blood components Via Leukapheresis for In vitro Dendritic Cell Investigations

    Scottsdale/Phoenix, Ariz.

    The purpose of this study is to collect blood cells as a healthy donor for use in research studies, which will focus especially on using the immune system’s cells to fight infection and cancer. Blood cells collected as part of participation in this Research Donor Program will be used strictly for laboratory experiments and will not be used for transfusion back into human beings.