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Working hypothesis
- 1. Patients who receive a Hematopoietic Stem Cell Transplantation (HSCT) who follow a comprehensive rehabilitation program, have fewer post-transplant complications, reduce the number of hospital stay days, and return to their daily lives more quickly.
- 2. The economic costs
Background
Chronic cold agglutinin disease (CAD) is mediated by monoclonal cold-reactive autoantibodies that bind to erythrocyte surface antigens, causing hemagglutination and complement-mediated hemolysis. Anemia is severe in one-third of patients (hemoglobin level 8.0 g/dL or lower). Cold-induced
This was a randomized, double-blind, placebo-controlled pilot study of SBI, colesevelam, and placebo in patients undergoing autologous HSCT for the clinical care of multiple myeloma.
The number of adults undergoing hematopoietic stem cell transplant (HSCT) has grown significantly over the past two
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants each will be enrolled in Part 1 of the study, and up to 10 participants will be enrolled in Part 2.
If you are
Overall design. This study is a Multicenter, Open-label, Phase 2 study of Carfilzomib Weekly +MP in Untreated Elderly MM. Eligible patients must have a symptomatic, untreated MM with a measurable disease. There is a dose escalation part in the study as the MTD remained to be determined for
Study Drug Administration:
If you are found to be eligible for this study, you will begin the first cycle of ibrutinib and carfilzomib. Each cycle is 28 days.
Ibrutinib Dosing:
You will take 2-4 ibrutinib capsules (depending on when you enter the study) every day with 1 cup (about 8 ounces) of
Multiple myeloma (MM) is one of the most common hematological diseases and besides the option of an allogeneic stem cell transplantation remains incurable.
Although autologous stem cell transplantation and new compounds such as bortezomib, thalidomide and lenalidomide have been implemented,
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth on Monday, Wednesday and Friday for 3 months.
In order to participate in this study you must register into and follow the requirements of the Revlimid REMS™ program of Celgene
PRIMARY ENDPOINTS:
Phase I • Determination of the MTD of the combination therapy
Phase II:
• Response rate (CR+PR)
SECONDARY ENDPOINTS:
- Overall Response Rate (ORR)
- Progression Free Survival (PFS)
- Time to Progression (TTP)
- Time to next therapy
A total of 56 patients may be enrolled in this
This is a phase 1/2a trial. Since this is an AHSCT conditioning regimen trial, only one cycle of therapy will be administered for each subject.
PHASE 1 The phase 1 component has a typical 3+3 design.
- Initially up to three subjects will be enrolled in each cohort starting at cohort 0 in the table
Describe succinctly and clearly the past findings which justify the plan for this project. A summary of the relevant literature in the area of interest and reports of previous studies should be included.
For majority of lymphoma patients who relapse after complete response or who are primary
Disease background:
MM is a plasma cell tumor. It accounted for an estimated 20,180 new cases of cancer and 11,170 deaths in the United States in 2010. With a prevalence of 23 per 100,000 people, MM is an orphan disease (prevalence <5:10,000). The median age at diagnosis is 60-65 years. Although MM
Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people.
Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of panobinostat based on when you join this study.
If you are enrolled in the first portion of Part A, up to 4 dose levels of panobinostat will be tested. Three (3) to 6 participants will
The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard MP treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response