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Monoclonal Antibodies
Venetoclax + Lintuzumab for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Actinium Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG ≤ 2
Refractory or relapsed AML which will include:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what the maximum tolerated dose is and how well it works in people with relapsed or refractory AML.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) that has come back or hasn't responded to treatment. They should have a certain level of kidney and liver function, controlled blast counts in the blood, and be able to perform daily activities with some limitations (ECOG ≤ 2). People can't join if they have active leukemia in the brain, HIV/Hepatitis B/C infections, recent strong drug interactions, previous high-dose radiation to vital organs, severe heart issues or other cancers within 2 years.Check my eligibility
What is being tested?
The study tests how safe and effective it is to add Lintuzumab-Ac225 to Venetoclax for AML patients who've relapsed or haven't responded well. Phase I finds the highest dose patients can take without too many side effects. Phase II checks how many achieve complete remission up to six months later without other AML treatments.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, lowered blood cell counts leading to increased infection risk or bleeding problems, fatigue, liver issues indicated by altered lab results, nausea or vomiting due to digestive system impact. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and do some daily activities.
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My AML has not responded to treatment or has come back.
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My condition did not improve after at least one treatment.
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My kidneys are working well.
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My leukemia has returned, with more than 5% of cells in my bone marrow being cancerous.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225
Phase II: Overall Response (CR + CRh + CRi)
Secondary outcome measures
Phase I and II: DFS
Phase I and II: Evaluate BH3 priming assay results
Phase I and II: Evaluate incidence of AEs and SAEs
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Phase I and Phase IIExperimental Treatment3 Interventions
Lintuzumab-Ac225 administered on Day 5 of each cycle for four cycles (unless in the 0.5 μCi/kg or 0.25 μCi/kg cohorts, where there is a potential for an additional four cycles, pending PI and Medical Monitor review).
Venetoclax taken on Days 1-21 of each cycle for up to 12 cycles.
Each cycle is 28 days, with a potential to expand to 42 days to allow for full hematologic recovery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lintuzumab-Ac225
2012
Completed Phase 2
~40
Venetoclax
2019
Completed Phase 3
~1990
Spironolactone
2005
Completed Phase 4
~7340
Find a Location
Who is running the clinical trial?
Actinium PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
224 Total Patients Enrolled
Avinash Desai, MDStudy ChairActinium Pharmaceuticals, Inc.
4 Previous Clinical Trials
195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received the maximum safe radiation dose to a vital organ.I haven't had cancer other than in my bone marrow in the last 2 years.My AML developed from a prior blood disorder.I have had a solid organ transplant but am not currently on immunosuppression therapy.I have HIV or hepatitis B/C with a detectable viral load.My AML did not respond to treatment for the current relapse.I can take care of myself and do some daily activities.I have a serious infection that is not under control.My AML has not responded to treatment or has come back.My condition did not improve after at least one treatment.My kidneys are working well.I have leukemia that has spread to my brain.I have a serious heart condition.I am taking FLT3 or IDH1/IDH2 inhibitors for my current cancer relapse without remission.I haven't taken strong or moderate CYP3A inducers in the last 7 days.My leukemia has returned, with more than 5% of cells in my bone marrow being cancerous.My blood blast count is 200 or less, controlled with medication if needed.You have a mental health condition that would make it difficult for you to take part in the study.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I and Phase II
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior research has been conducted regarding the efficacy of Lintuzumab-Ac225?
"Lintuzumab-Ac225 was initially explored in 2013 at Brigham and Women's Hospital. To date, 144 trials have been successfully completed. Currently, 247 studies are actively recruiting participants with a hefty amount of these occurring in Louisiana's New Orleans area."
Answered by AI
Are there multiple locations in this state conducting the research experiment?
"This clinical trial is currently being hosted at 5 distinct sites, which are located in New Orleans, Seattle, and Los Angeles along with two other locales. To reduce travel time when enrolling for the study, it's preferable to select a location close by."
Answered by AI
What is the intended outcome of this clinical experiment?
"This clinical trial's primary intent, which will take place over a maximum 6 month period, is to identify the Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225. Other objectives include measuring patients' Overall Response rate, Minimal Residual Disease status and Disease-free Survival rates."
Answered by AI
What is the aggregate figure of participants in this experiment?
"Correct. Clinicaltrials.gov affirms that this medical trial is still recruiting patients - it was first published on January 15th 2020 and has been revised as recently as February 22nd 2022, with 38 participants sought from 5 sites."
Answered by AI
Does this research protocol currently accept new participants?
"Correct. Clinicaltrials.gov lists this trial as actively seeking participants, with the study originally posted on January 15th 2020 and last edited February 22nd 2022. The research is currently looking to enrol 38 patients across 5 different medical centres."
Answered by AI
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