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Epigenetic Modifier

OPB-111077 + Decitabine + Venetoclax for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Margaret Kasner, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

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 studying a combination of drugs to treat patients with acute myeloid leukemia that has not responded to previous treatment, has come back, or is newly diagnosed and ineligible for intensive chemotherapy.

Eligible Conditions

Acute Myeloid Leukemia
Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of grade 4, non-hematologic dose limiting toxicities assessed by National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0

Secondary outcome measures

Adenosine triphosphate (ATP) generation as determined by bone marrow biopsy

Apoptotic rate in blood and bone marrow assessed by apoptosis assays

Cellular proliferation in blood and bone marrow assessed by proliferation assays

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (STAT inhibitor OPB-111077, venetoclax, decitabine)Experimental Treatment4 Interventions

INDUCTION CYCLE 1: Patients receive STAT inhibitor OPB-111077 PO QD on days 1-28, and venetoclax PO QD on days 4-28 of cycle 1. Patients also receive decitabine IV over approximately 1 hour on days 4-8 of cycle 1. Patients who achieve complete remission (CR) after 1 cycle move on to Maintenance, and patients who do not achieve a CR move on to Cycle 2. INDUCTION CYCLE 2: Patients receive STAT inhibitor OPB-111077, venetoclax, and decitabine as in Induction Cycle 1. Patients who achieve CR, CRi, PR, or stable disease (or clinically significant hematologic improvement as determined by the investigator) move on to Maintenance. MAINTENANCE: Patients receive STAT inhibitor OPB-111077, venetoclax, and decitabine as in Induction Cycle 1. 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

STAT Inhibitor OPB-111077

2017

Completed Phase 1

~40

Decitabine

2004

Completed Phase 3

~1680

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,874 Total Patients Enrolled

Otsuka America PharmaceuticalIndustry Sponsor

66 Previous Clinical Trials

28,406 Total Patients Enrolled

Margaret Kasner, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

6 Previous Clinical Trials

201 Total Patients Enrolled

Media Library

Decitabine (Epigenetic Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT03063944 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Treatment (STAT inhibitor OPB-111077, venetoclax, decitabine)

Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03063944 — Phase 1

Decitabine (Epigenetic Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03063944 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this experiment?

"This particular medical study is not currently accepting applicants. It was initially posted on March 17, 2017 and last updated February 4, 2022. However, there are 1536 different clinical trials enrolling patients with leukaemia, myeloid acute and 303 studies looking for participants in the STAT Inhibitor OPB-111077 trial."

Answered by AI

What afflictions can be remedied by utilizing STAT Inhibitor OPB-111077?

"The STAT Inhibitor OPB-111077 is a viable medical treatment for refractory anemia, intermediate-1 risk category according to the IPSS score and chronic lymphocytic leukemia (CLL)."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Unfortunately, no longer are any more patients being sought after for this medical trial. Originally posted on March 17th 2017 and last updated February 4th 2022, it is now closed to new applicants. However, if you're searching for alternatives there are currently 1536 clinical trials accepting participants with leukemia or myeloid acute and 303 studies recruiting individuals that may benefit from STAT Inhibitor OPB-111077."

Answered by AI

Has STAT Inhibitor OPB-111077 been trialled previously within a research context?

"As of now, 303 ongoing studies are investigating the effects of STAT Inhibitor OPB-111077 with 42 trials in Phase 3. Though Edmonton, Alberta is a major hub for this research topic, there are 8577 locations worldwide running similar investigations."

Answered by AI

Has OPB-111077 been sanctioned by the FDA for therapeutic use?

"Due to the preliminary nature of this trial, STAT Inhibitor OPB-111077 received a score of 1. This is because there is limited data available demonstrating efficacy and safety for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

STAT Inhibitor OPB-111077, Decitabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia That Is Refractory, Relapsed or Newly Diagnosed and Ineligible for Intensive Chemotherapy

2017. "STAT Inhibitor OPB-111077, Decitabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia That Is Refractory, Relapsed or Newly Diagnosed and Ineligible for Intensive Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03063944.