A type of research study that tests how a drug, medical device, or treatment approach works in people. There are several types of clinical trials. Treatment trials test new treatment options. Diagnostic trials test new ways to diagnose a disease. Screening trials test the best way to detect a disease or health problem. Quality of life (supportive care) trials study ways to improve the comfort of people with chronic illness. Prevention trials look for better ways to prevent disease in people who have never had the disease.
Tests a new drug or treatment in a small group to see if it is safe.
Expands the study to a larger group of people to find out if it works.
Expands the study to an even larger group of people to compare it to the standard treatment for the disease.
Takes place after the drug or treatment has been licensed and marketed to find out the long-term impact of the new treatment.
Description: 404-patient multicenter, randomized, open-label study in acute myeloid leukemia (AML) patients who failed or relapsed following prior intensive chemotherapy.
Study Title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice (TC) in Previously Treated Acute Myeloid Leukemia (AML)
For more information on this study and a full list of eligibility requirements please visit www.clinicaltrials.gov, identifier NCT02920008.
This agent is investigational, efficacy and safety have not been established. There is no guarantee that this agent will become commercially available.
Description: 408-Patient multicenter, randomized, open-label study in myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) after failure of prior azacitidine, decitabine, or both.
Study Title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice (TC) in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents
For more information on this study and a full list of eligibility requirements please visit www.clinicaltrials.gov, identifier NCT02907359.
This agent is investigational, efficacy and safety have not been established. There is no guarantee that this agent will become commercially available.
Description: 408-Patient multicenter, randomized, open-label study in myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) after failure of prior azacitidine, decitabine, or both.
Study Title: Phase 3, Randomized, Open-Label, Crossover Study of Oral ASTX727 (Cedazuridine and Decitabine Oral Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
For more information on this study and a full list of eligibility requirements please visit www.clinicaltrials.gov, identifier NCT03306264.
This agent is investigational, efficacy and safety have not been established. There is no guarantee that this agent will become commercially available.
INternational Study of Phase III Intravenous RigosErtib
STUDY DESCRIPTION
A Phase III, international, randomized, controlled study of Rigosertib + best supportive care versus physician’s choice of treatment + best supportive care in patients with myelodysplastic syndrome (MDS) after failure of a hypomethylating agent (HMA).
PRIMARY ENDPOINTS
Overall survival in the intention-to-treat population and in patients with very high risk per the Revised International Prognostic Scoring System (Greenberg et al, Blood 2012).
INTERNATIONAL TRIAL
More than 200 trial sites, globally.
For additional information on this study, please call the INSPIRE help line at 1-267-759-3676 or visit www.clinicaltrials.gov, identifier: NCT02562443.
Rigosertib is an investigational agent and is not approved by the FDA or other regulatory agencies worldwide as a treatment for any indication.
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia.
Takeda Pharmaceuticals International Inc. is initiating a Phase 3 clinical study with the study drug Pevonedistat. The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single agent azacitidine in participants with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low blast acute myelogeneous leukemia. This study will look at the overall response, event free survival, and overall survival in people who take pevonedistat and azacitidine when compared to people who take single agent azacitidine.
The study will enroll approximately 450 participants. Once enrolled, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in a 28 day treatment cycles:
All participants will receive azacitidine via the intravenous or subcutaneous route. Participants randomized to the combination arm also will receive pevonedistat intravenous infusion).
This multi-center trial will be conducted worldwide.
Patients may qualify for this study if:
In order to refer a patient with MDS, CMML, or low blast AML for enrollment to this study and review eligibility criteria, physicians/health care providers should visit: www.clinicaltrials.gov (NCT03268954)
Contact: Takeda Study Registration Call Center +1-877-825-3327; medicalinformation@tpna.com
Takeda Oncology is a trademark of Takeda Pharmaceutical Company Limited. Millennium Pharmaceuticals, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. ©2016 Millennium Pharmaceuticals, Inc.
Myelodysplastic Syndromes (MDS) remain difficult to treat, in part because these blood disorders are rare and researchers don’t have enough samples from patients to study. The National Myelodysplastic Syndromes Natural History Study is a chance to help improve MDS treatment in the future. For the first time ever in the U.S., this study will collect information and samples from patients with MDS, and follow those patients for years to answer questions about what causes MDS, how it gets worse over time, and what treatments are most likely to work. This National Institutes of Health (NIH) sponsored study will create a public resource by collecting clinical information and blood, bone marrow, and tissue samples from up to 2,000 people with, or suspected to have, MDS.
You may be eligible for this study if you are at least 18 years old and either:
OR
If you participate in this study, you will receive your normal care and treatment from your doctor but will not receive additional treatment as part of this study. Instead, your normal care and treatment will be followed. This will also include following your quality of life during your time on the study.
For more information on the study, including how to find a participating hospital near you, please visit the study website at https://thenationalmdsstudy.net/ or https://clinicaltrials.gov/ (NCT02775383).
Current Status: Part 1 recruitment complete; Part 2 is not yet open for recruitment. For additional details, refer to the Geron press release (12Sep2016) at http://ir.geron.com/phoenix.zhtml?c=67323&p=irol-newsArticle&ID=2201055.
Janssen Research & Development, LLC is conducting a Phase 2/3 clinical study referred to as “IMerge”, with the study drug Imetelstat, which is a first-in-class telomerase inhibitor. With its novel mechanism of action, Imetelstat may provide clinical benefit to MDS patients. In this study, Imetelstat is administered as a 2-hour intravenous infusion every 28 days.
IMerge is a study for people with MDS who need blood transfusions due to anemia (low red blood cell counts). People with low or intermediate-1 risk MDS that has relapsed or is refractory to Erythropoiesis-Stimulating Agents (ESAs) treatment are enrolled in the study. This study is being conducted at multiple hospitals and institutions around the world, in approximately 80 sites globally.
For more information about this clinical study, please visit www.clinicaltrials.gov (NCT02598661).
This is a phase 2 study of selinexor for MDS patients (with up to 30% blasts) and CMML who have received prior decitabine or 5-azacytidine. The primary endpoint is to determine the response rate of this novel drug in patients who have refractory or relapsed disease after receiving either decitabine or 5-azacytidine.
Secondary Objectives of the study are to determine if selinexor improves the survival of people with MDS and CMML after receiving 5-azacytidine and CMML. Additional secondary endpoints include an assessment of response duration and tolerability of selinexor, and to perform research studies on blood and bone marrow samples to better understand the mechanism of selinexor in MDS and CMML.
NCT02228525
Pfizer is conducting a clinical study to determine the safety, efficacy, PK and PD of Glasdegib (PF-04449913) or placebo when combined with azacitidine in patients with previously untreated Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, or Chronic Myelomonocytic Leukemia (CMML).
This study is being conducted at multiple hospitals and institutions around the world and includes two components: (a) a Phase 1b open -label safety lead in component and (b) a Phase 2 randomized double-blind component. In the Phase 1b component, approximately 10 patients will be enrolled and will receive Glasdegib (PF-04449913) and azacitidine and in the Phase 2 component, 160 patients will be randomized to receive to receive either Glasdegib (PF-04449913) (Arm A) or placebo (Arm B) in combination with azacitidine.
If you are a physician or health care provider and would like to refer a patient for enrollment into this clinical trial OR if you are an MDS, AML, or CMML patient please see additional information and contact details at the following websites:
