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Trial record 2 of 4 for:    Tegavivint

Tegavivint for the Treatment of Relapsed or Refractory Leukemia

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ClinicalTrials.gov Identifier: NCT04874480
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase I trial is to find out the best dose and side effects of tegavivint in treating patients with leukemia that has come back (relapsed) or does not response to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint in combination with decitabine may help control the disease.

Condition or disease Intervention/treatment Phase
Recurrent Leukemia Refractory Leukemia Drug: Decitabine Drug: Tegavivint Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint in patients with relapsed and refractory acute myeloid leukemia (AML). (Phase I dose escalation) II. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint combined with decitabine in patients with relapsed and refractory acute myeloid leukemia (AML). (Combination cohort)

SECONDARY OBJECTIVES:

I. To assess the safety profile of tegavivint as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Phase I dose escalation) II. To explore the efficacy (complete remission [CR], complete remission without blood count recovery [CRi], or partial remission [PR], of tegavivint as a single-agent in patients with relapsed/refractory (R/R) AML. (Phase I dose escalation) III. To assess overall survival (OS), and disease-free survival (DFS) in patients with R/R AML treated with tegavivint. (Phase I dose escalation) IV. To assess the duration of disease control defined as first date of disease control identified (either CR/CRi, PR or SD) until the date of progression. (Phase I dose escalation) V. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint. (Phase I dose escalation) VI. To assess the safety profile of tegavivint in combination with decitabine as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Combination cohort) VII. To explore the efficacy (complete response [CR], complete response without blood count recovery [CRi], or partial response [PR], of tegavivint in combination with decitabine in patients with R/R AML. (Combination cohort) VIII. To assess overall survival (OS), and disease free survival (DFS) in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort) IX. To assess the duration of disease control defined as first date of disease control identified (either CR/ CRi, PR or SD) until the date of progression. (Combination cohort) X. To explore biomarkers of response and resistance in patients with R/R AML treated with tegavivint + decitabine. (Combination cohort)

OUTLINE: This is a dose-escalation study.

PART I: Patients receive tegavivint intravenously (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.

After completion of study treatment, patients are followed up at 30 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Tegavivint (BC-2059) in Patients With Relapsed and Refractory Leukemias
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Treatment (tegavivint, decitabine)

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.

Drug: Decitabine
Given IV
Other Names:
  • 5-Aza-2''-deoxycytidine
  • Dacogen
  • Decitabine for Injection
  • Deoxyazacytidine
  • Dezocitidine

Drug: Tegavivint
Given IV
Other Names:
  • BC 2059
  • BC-2059
  • BC2059
  • Tegatrabetan




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 2 years ]
    Adverse events will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.

  2. Response rate [ Time Frame: Up to 2 years ]
    Response rate will be estimated alone with 95% confidence interval.

  3. Overall survival [ Time Frame: From date of treatment start until date of death due to any cause, assessed up to 2 years ]
    Will be estimated using the Kaplan-Meier method.

  4. Disease free survival [ Time Frame: From date of complete response (CR), or complete remission without blood count recovery (CRi) until the date of first objective documentation of disease-relapse or death, assessed up to 2 years ]
    Will be estimated using the Kaplan-Meier method.

  5. Duration of disease control [ Time Frame: Up to 2 years ]
    Will be estimated using the Kaplan-Meier method.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia for which no available standard therapies are indicated or anticipated to result in a durable response
  • Age >= 18 years
  • Patients must not have had leukemia therapy for 14 days prior to starting tegavivint (BC-2059). However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study
  • Bilirubin =< 2.5 mg/dL
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) - or =< 5 x ULN if related to leukemic involvement
  • Creatinine =< 1.5 x ULN
  • Known cardiac ejection fraction of > or = 45% within the past 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
  • Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Exclusion Criteria:

  • Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided
  • Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient with documented hypersensitivity to any of the components of the therapy program
  • Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible
  • Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation
  • Prior treatment with tegavivint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874480


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tapan M. Kadia, MD    713-792-7305    tkadia@mdanderson.org   
Principal Investigator: Tapan M. Kadia, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Tapan M Kadia M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04874480    
Other Study ID Numbers: 2020-0616
NCI-2021-03253 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0616 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors