Hematología

A continuación, se enumeran los ensayos clínicos actuales.

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

1. A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients

   Rochester, Minn., Albert Lea, Minn., Eau Claire, Wis.

   The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

2. Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.

3. A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.

4. MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

   Rochester, Minn., Mankato, Minn., Jacksonville, Fla., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.

5. 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.

6. 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.

7. 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).

    

8. 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.

9. 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.

10. 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.