Your session is about to expire
← Back to Search
Chemotherapy
Venetoclax-Navitoclax Combo for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Led By Guru Subramanian Guru Murthy, MD, MS
Research Sponsored by Medical College of Wisconsin
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 up to three years
Awards & highlights
Study Summary
This trial studies the safety of a drug combo to treat a blood cancer.
Who is the study for?
Adults over 18 with relapsed or refractory acute myeloid leukemia (AML) who've had at least one prior treatment can join this trial. They must have certain organ functions within specific ranges, not be pregnant or breastfeeding, and agree to use contraception. People with HIV/AIDS, active infections like hepatitis B/C, recent transplants or other cancer treatments are excluded.Check my eligibility
What is being tested?
The study is testing the safety of combining venetoclax-navitoclax with cladribine-based salvage therapy for AML. It's an open-label phase I trial where everyone knows what treatment they're getting. The drugs being tested include different doses of navitoclax and venetoclax along with chemotherapy agents like cladribine and cytarabine.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood cell counts leading to increased infection risk, liver issues indicated by elevated enzymes in blood tests, bleeding complications due to low platelets, and possibly heart problems as reflected by changes in ejection fraction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose for Navitoclax for the CLAG-M Backbone
Recommended Phase 2 Dose of Navitoclax for the Cladribine-Low Dose Cytarabine Backbone
Trial Design
10Treatment groups
Experimental Treatment
Group I: Cladribine-Low Dose Cytarabine Backbone Dose Maximum Tolerated Dose (MTD)Experimental Treatment8 Interventions
The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.
Group II: Cladribine-Low Dose Cytarabine Backbone Dose Level 2Experimental Treatment4 Interventions
This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
Group III: Cladribine-Low Dose Cytarabine Backbone Dose Level 1Experimental Treatment4 Interventions
This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
Group IV: Cladribine-Low Dose Cytarabine Backbone Dose Level 0Experimental Treatment4 Interventions
This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
Group V: Cladribine-Low Dose Cytarabine Backbone Dose Level -1Experimental Treatment4 Interventions
Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
Group VI: CLAG-M Backbone Maximum Tolerated DoseExperimental Treatment10 Interventions
The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.
Group VII: CLAG-M Backbone Level 2Experimental Treatment6 Interventions
This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
Group VIII: CLAG-M Backbone Level 1Experimental Treatment6 Interventions
This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
Group IX: CLAG-M Backbone Level 0Experimental Treatment6 Interventions
This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and granulocyte colony-stimulating factor (G-CSF).
Group X: CLAG-M Backbone Level -1Experimental Treatment6 Interventions
Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Granulocyte Colony-Stimulating Factor
2016
Completed Phase 2
~50
Mitoxantrone
2008
Completed Phase 3
~1540
Cladribine
2014
Completed Phase 4
~4390
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,677 Total Patients Enrolled
Guru Subramanian Guru Murthy, MD, MSPrincipal InvestigatorMedical College of Wisconsin
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current open vacancies in this research program?
"According to clinicaltrials.gov's records, this trial is not currently enrolling patients. It was first posted on October 1st 2023 and has since experienced its last update in August 17th of the same year. Nevertheless, there are 1484 other research studies actively looking for volunteers at present."
Answered by AI
What can be expected in terms of safety when using Cladribine-Low Dose Cytarabine Backbone Dose Level -1 for patient treatment?
"Due to the initial stage of testing, our team has assigned Cladribine-Low Dose Cytarabine Backbone Dose Level -1 a safety rating of 1. This is because there is only limited data available on both its efficacy and security profile."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger