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Monoclonal Antibodies
MBG453 for Leukemia
Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
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.
Eligible Conditions
- Leukemia
- Myeloid Leukemia
- Bone Marrow Disease
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Blood Diseases
- Preleukemia
- Chronic Myelomonocytic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs)
Safety of MBG453 single agent treatment or MBG453 in combination with PDR001 or PDR001 and/or MBG453 in combination with decitabine or azacitidine.
Tolerability of MBG453 single agent treatment or MBG453 in combination with PDR001 or PDR001 and/or MBG453 in combination with decitabine or azacitidine.
Secondary outcome measures
AUC of PDR001, MBG453, decitabine and azacitidine.
Best Overall Response (BOR)
Cmax of PDR001, MBG453, decitabine and azacitidine
+7 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: MBG453 and PDR001Experimental Treatment2 Interventions
MBG453 in combination with PDR001
Group II: MBG453Experimental Treatment1 Intervention
MBG453 alone
Group III: Decitabine, PDR001 and MBG453Experimental Treatment3 Interventions
Decitabine in combination with PDR001 and MBG453
Group IV: Decitabine and PDR001Experimental Treatment2 Interventions
Decitabine in combination with PDR001
Group V: Decitabine and MBG453Experimental Treatment2 Interventions
Decitabine in combination with MBG453
Group VI: Azacitidine and MBG453Experimental Treatment2 Interventions
Azacitidine in combination with MBG453
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1410
Decitabine
2004
Completed Phase 3
~1680
PDR001
2016
Completed Phase 2
~2700
MBG453
2017
Completed Phase 1
~250
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,085 Total Patients Enrolled
152 Trials studying Leukemia
23,708 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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