Tegavivint for the Treatment of Relapsed or Refractory Leukemia

NCT04874480 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2020-0616NCI-2021-03253
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Leukemia; Refractory Leukemia

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  Adverse events will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.

  Up to 2 years

• Response rate

  Response rate will be estimated alone with 95% confidence interval.

  Up to 2 years

• Overall survival

  Will be estimated using the Kaplan-Meier method.

  From date of treatment start until date of death due to any cause, assessed up to 2 years

• Disease free survival

  Will be estimated using the Kaplan-Meier method.

  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

• Duration of disease control

  Will be estimated using the Kaplan-Meier method.

  Up to 2 years

Study Arms (1)

Treatment (tegavivint, decitabine)

EXPERIMENTAL

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; Drug: Tegavivint

Interventions

Decitabine DRUG

Given IV

Also known as: 5-Aza-2''-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine

Treatment (tegavivint, decitabine)

Tegavivint DRUG

Given IV

Also known as: BC 2059, BC-2059, BC2059, Tegatrabetan

Treatment (tegavivint, decitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia

Interventions

Decitabine; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Tapan M Kadia

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 5, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)