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MBG453 for Bone Marrow Disease
Study Summary
This trial is testing the safety and tolerability of two drugs, MBG453 and PDR001, either alone or in combination with each other or with other drugs. The goal is to find recommended doses for future studies.
- Bone Marrow Disease
- Leukemia
- Myeloid Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Blood Diseases
- Preleukemia
- Chronic Myelomonocytic Leukemia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- This is a specific group or category within the clinical trial called "Arm 6".You have a certain type of blood disorder called MDS or MDS/MPN, and it is at an intermediate or high risk level. If you are eligible and willing to receive standard chemotherapy or a stem cell transplant, you cannot participate in the study.You have a type of blood cancer called AML that has not responded to previous treatments or has come back after treatment.You have a certain type of blood disorder called MDS or MDS/MPN, and it is considered intermediate or high-risk. If you are eligible and willing to receive standard chemotherapy or a stem cell transplant, you will not be able to participate.You have already been treated with certain medications called hypomethylating agents for a specific type of blood cancer called AML or MDS.You have a type of blood disorder called MDS or MDS/MPN and have not responded well to a specific type of medication called hypomethylating agents.There may be additional rules or requirements that apply to determine if you can participate in the study.
- Group 1: Decitabine and PDR001
- Group 2: Decitabine and MBG453
- Group 3: Decitabine, PDR001 and MBG453
- Group 4: MBG453
- Group 5: MBG453 and PDR001
- Group 6: Azacitidine and MBG453
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the primary objective of this experiment?
"According to Novartis Pharmaceuticals, the primary outcome for this trial will be tracked over a two-year period and focus on MBG453's tolerability when used as a single agent or in combination with PDR001. Additionally, the study aims to measure secondary outcomes such as overall response rate (ORR), Tmax of each medication, and Cmax of each drug."
How extensive is the patient pool for this clinical research?
"This medical study is not presently open to recruitment. It was first made available on July 6th, 2017 and last updated November 14th 2022. Those looking for alternate trials can search through the 2840 studies actively recruiting patients with hematologic diseases or investigate one of the 295 MBG453 investigations that are still seeking participants."
Does MBG453 possess the necessary licensure from the FDA?
"MBG453's safety was rated a 1 on our internal scale due to Phase 1 trials, which suggest limited evidence of efficacy and security."
What is the most frequent application of MBG453?
"MBG453 is typically given to patients undergoing induction chemotherapy. It has also demonstrated efficacy in treating a variety of conditions, including ipss risk category intermediate-2, refractory anemias, leukemia myelocytic and acute."
Are there any vacancies for enrolment in this research endeavor?
"Unfortunately, no more patients are being admitted to this particular research trial. This project was initially posted on July 6th 2017 and last updated November 14th 2022. For those who still seek a medical study, 2840 trials for hematologic diseases and 295 studies involving MBG453 are currently recruiting participants."
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