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MDM2 Inhibitor
HDM201 + MBG453/Venetoclax for Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
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
- ECOG performance status ≤ 1
- High-risk MDS patient (high and very high-risk groups according to rIPSS) who have failed hypomethylating agent therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 24
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat leukemia or high-risk myelodysplastic syndrome (MDS). The first part of the trial will test how well the subjects tolerate the new combination of drugs. The second part of the trial will test the preliminary effectiveness of the new combination of drugs.
Who is the study for?
Adults with high-risk MDS who failed hypomethylating therapy, or AML patients unfit for standard chemotherapy or those relapsed/refractory after ≤3 prior therapies. Participants must have TP53wt status without mutations in specific gene exons and be able to undergo bone marrow procedures.Check my eligibility
What is being tested?
This phase 1b trial tests HDM201 combined with either MBG453 (arm 1) or venetoclax (arm 2) in parallel groups to evaluate safety, tolerability, and preliminary effectiveness against AML or high-risk MDS. Dosages will be adjusted to determine the maximum tolerated dose.See study design
What are the potential side effects?
Potential side effects may include digestive issues affecting drug absorption, severe allergic reactions similar to other monoclonal antibodies, bleeding disorders, and possibly autoimmune disease symptoms in arm 1.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I have high-risk MDS and treatments to modify my DNA have not worked.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose intensities
Frequency of dose interuptions
Frequency of dose reductions
+3 moreSecondary outcome measures
Best Overall Response (BOR)
Changes from baseline in GDF-15 (Treatment arm 1 HDM201+MBG453 and treatment arm 2 HDM201+venetoclax)
Changes from baseline in soluble TIM-3 (Treatment arm 1 HDM201+MBG453)
+17 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
2Treatment groups
Experimental Treatment
Group I: treatment arm2: HDM201+venetoclaxExperimental Treatment2 Interventions
Phase Ib (escalation)
Group II: treatment arm1: HDM201+MBG453Experimental Treatment2 Interventions
Phase Ib (escalation)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBG453
2017
Completed Phase 1
~250
HDM201
2015
Completed Phase 1
~600
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,302 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all my pre-disease activities without restriction.I am willing and able to have bone marrow tests as required by this study.You have a known or suspected autoimmune disease and are receiving treatment. This criterion only applies to participants in treatment arm 1.I do not have any current bleeding disorders or a history of serious bleeding problems.I have acute promyelocytic leukemia with PML-RARA.I am taking mdm2 or mdm4 inhibitors with TIM-3 inhibitors for my treatment.My AML has returned or didn't respond after 1 to 3 treatments, and I can't have standard therapy.I have AML and can't undergo standard chemotherapy, and I'm not planning to have a stem cell transplant.I have high-risk MDS and treatments to modify my DNA have not worked.My tumor is TP53 wild-type with no mutations in specific areas, confirmed by a recent bone-marrow test.I had a stem cell transplant in the last 6 months or need medicine for GvHD.I am taking mdm2 or mdm4 inhibitors with a Bcl-2 inhibitor.I have not been treated with drugs that work the same way before.I do not have GI disorders affecting medication absorption.I am 18 years or older and have signed the informed consent form.You have had serious allergic reactions in the past to any ingredients in the study drug or other similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: treatment arm1: HDM201+MBG453
- Group 2: treatment arm2: HDM201+venetoclax
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the potential risk of HDM201 to those taking part in a trial?
"Due to the preliminary nature of Phase 1 trials, HDM201's safety rating was judged with caution and received a score of 1."
Answered by AI
Are there any other precedents of HDM201 being used for clinical experimentation?
"Currently, 230 trials studying HDM201 are on-going with 29 of them in the final phase. Though most studies based around this medication are located in Boston, MA, there are 7528 sites running clinical investigations into it's potential benefits."
Answered by AI
Is the study open to new enrollees?
"Affirmative. According to the information provided on clinicaltrials.gov, this research is actively seeking enrollees. The trial was first published on June 24th 2019 and its most recent update occurred November 25th 2022. At present, 1 medical centre has been chosen to accommodate a total of 80 participants in the study."
Answered by AI
How many individuals are enrolled in this clinical trial?
"Affirmative. The particulars of the clinical trial, which was initially introduced on 24th June 2019, is currently available on clinicaltrials.gov and actively enrolling patients. 80 individuals are needed for this 1-site study before it can proceed to completion."
Answered by AI
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