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DNA Methyltransferase Inhibitor
Tegavivint for Leukemia
Phase 1
Waitlist Available
Led By Tapan M Kadia
Research Sponsored by M.D. Anderson Cancer Center
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 2 years
Awards & highlights
Study Summary
This trial is to find the best dose and side effects of tegavivint for treating leukemia that has come back or doesn't respond to treatment.
Who is the study for?
Adults with relapsed or refractory leukemia who haven't had leukemia treatment in the past 14 days (except hydroxyurea until starting this trial) can join. They must have acceptable liver and kidney function, a heart ejection fraction of at least 45%, and be physically able to participate (ECOG <=2). Women must not be pregnant, all participants must agree to use contraception, and they cannot have uncontrolled illnesses or hypersensitivity to the drugs used.Check my eligibility
What is being tested?
This phase I trial is testing Tegavivint combined with Decitabine for adults with leukemia that has returned after treatment or hasn't responded to previous treatments. The goal is to determine the best dose of Tegavivint and understand its side effects when used alongside Decitabine.See study design
What are the potential side effects?
Potential side effects include risks associated with enzyme inhibition that may affect cell growth, which could lead to fatigue, digestive issues, blood disorders, possible organ inflammation due to drug interactions, as well as specific reactions related to each drug's profile.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Disease free survival
Duration of disease control
Incidence of adverse events
+2 moreOther outcome measures
Biomarkers of response and resistance
Side effects data
From 2022 Phase 2 trial • 14 Patients • NCT0405584457%
Febrile neutropenia
57%
Neutrophil count decreased
21%
Infections and infestations - Other, specify
21%
Lung infection
21%
Bacteremia
21%
Sepsis
14%
Aspartate aminotransferase increased
14%
Alanine aminotransferase increased
14%
Infections and infestations - Other,
7%
Mucositis oral
7%
White blood cell decreased
7%
Syncope
7%
Upper gastrointestinal
7%
Sinusitis
7%
Hyperglycemia
7%
Hypertension
7%
Encephalopathy
7%
Hepatobiliary disorders
7%
Blood and lymphatic system
7%
General disorders and administration
7%
INR increased
7%
Typhlitis
7%
Upper gastrointestinal hemorrhage
7%
Hepatic failure
7%
Injury, poisoning and procedural
7%
Blood and lymphatic system disorders - Other, specify
7%
Fatigue
7%
Intracranial hemorrhage
7%
Gastrointestinal disorders - Other,
7%
Disease progression
7%
Fever
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
Neoplasms benign, malignant and
7%
Alanine aminotransferase
7%
Tooth infection
7%
Gastrointestinal disorders - Other, specify
7%
Pericardial effusion
7%
General disorders and administration site conditions - Other, specify
7%
Hepatic infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Decitabine + Ruxolitinib + DLI
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tegavivint, decitabine)Experimental Treatment2 Interventions
PART I: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PART II: Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 and decitabine IV over 30-60 minutes on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Tegavivint
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,772 Total Patients Enrolled
451 Trials studying Leukemia
31,458 Patients Enrolled for Leukemia
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,164 Total Patients Enrolled
12 Trials studying Leukemia
1,064 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active, uncontrolled brain leukemia.I am willing to use birth control during the study.I can take care of myself but might not be able to do heavy physical work.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I understand the study's requirements and have signed the consent form.My acute myeloid leukemia has returned or is not responding to treatment, and no standard therapies are expected to work.I am not pregnant or breastfeeding.I am 18 years old or older.I haven't had leukemia treatment in the last 14 days, but I may have taken hydroxyurea.My heart's pumping ability is confirmed to be normal or near normal.I am allergic to one or more of the drugs used in the treatment.I have previously been treated with tegavivint.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tegavivint, decitabine)
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.
How many participants are included in the current clinical trial?
"Affirmative, the clinical trials website indicates that this research project is currently recruiting. The trial began on September 27th 2021 and the last update was made February 2nd 2022. 54 volunteers are needed from a single location."
Answered by AI
What health concerns is Tegavivint most frequently used to address?
"Patients with intermediate-2, high risk, and refractory anemias can find relief from Tegavivint."
Answered by AI
Could you elucidate the hazards associated with Tegavivint usage?
"As this is a Phase 1 trial, our team has given Tegavivint a score of 1 due to the limited amount of data available surrounding its efficacy and safety."
Answered by AI
Is this trial still recruiting participants?
"Affirmative, clinicaltrials.gov states that this research project is currently recruiting patients. It was initially posted on September 27th 2021 and has most recently been updated February 2nd 2022. 54 individuals are required at a single location for the trial to commence."
Answered by AI
What research has been performed to assess the efficacy of Tegavivint?
"Currently, 102 clinical trials are underway investigating the use of Tegavivint. 15 of these active studies have progressed to Phase 3 and most occur in Philadelphia, Pennsylvania; however other sites across 1483 locations worldwide are also running research."
Answered by AI
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