Hematología

A continuación, se enumeran los ensayos clínicos actuales.

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

1. The Impact of a Geriatric Assessment in Elderly Patients with Multiple Myeloma

   Rochester, Minn.

   The purpose of this study is to evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (≥ 65 years) with multiple myeloma (MM).

   Multiple myeloma (MM) is a blood cancer that affects a type of white cell called plasma cell. It mainly affects older individuals and has an average age at diagnosis of 69 years. 

2. Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

   Rochester, Minn.

   This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy 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. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

3. A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383. 

4. A Registry for the Collection of Biological and Clinical Data for Studies of Immune System Related Blood Disorders

   Rochester, Minn.

   The purpose of this study is to develop and maintain a registry of clinical data and biological specimens from patients with immune system related blood disorders, for use in future studies of disease source, diagnosis, treatment, and prognosis.

5. A Study of DNA/RNA Sequencing Results on the Clinical Management of Patients with Advanced Malignancies

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

   The purpose of this study is to assess practice patterns and changes in treatment recommendations based on the results obtained from a clinically available, comprehensive next generation DNA/RNA sequencing assay. A database of paired clinical and sequencing data will also be established for future research.

6. A Study to Evaluate APG2575 Combined with Novel Therapeutic Regimens To Treat Subjects with Relapsed or Refractory Multiple Myeloma and Immunoglobulin Light Chain Amyloidosis

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).

    

7. Clinical and Molecular Characteristics of Histiocytic Disorders

   Rochester, Minn.

   The purpose of this study is to assess the presence of various molecular markers in histiocytic disorders. In addition to this, to review clinical records of the patients with these disorders to assess the role of the molecular markers in patient outcomes.

8. Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.

9. ALEX Study: A Randomized, Phase III Study Comparing Alectinib with Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

   Scottsdale/Phoenix, Ariz.

   This randomized, active controlled, multicenter Phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with critozinib treatment in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized in a 1:1 ratio to receive either alectinib, 600 mg orally twice daily (BID), or critozinib, 250 mg orally BID. Patients will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death occurs. The study is expected to last approximately 42 months.

10. A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared with Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

    Jacksonville, Fla.

    This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).

    Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70 mg/m2) on Days 1 and 2 of each 28-day cycle.

    Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or 2 years since treatment start, whichever comes first. Anticipated time on study is up to 5 years.