Tegavivint for the Treatment of Relapsed or Refractory Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2027-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

NCT03628053

Acute Lymphoblastic Leukemia

WITHDRAWN PHASE3

Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT00079378

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) +7 more

COMPLETED PHASE1

High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia

NCT02551718

Recurrent Acute Leukemia of Ambiguous Lineage Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia +3 more

COMPLETED NA

Pevonedistat and Decitabine in Treating Patients With High Risk Acute Myeloid Leukemia

NCT03009240

Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia +3 more

ACTIVE_NOT_RECRUITING PHASE1

TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts

NCT03816319

Myelodysplastic Syndrome With Excess Blasts Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome +4 more

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Leukemia Refractory Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Given IV

Tegavivint

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decitabine

Given IV

Intervention Type DRUG

Tegavivint

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

5-Aza-2''-deoxycytidine Dacogen Decitabine for Injection Deoxyazacytidine Dezocitidine BC 2059 BC-2059 BC2059 Tegatrabetan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No