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Prodrug

OBI-3424 for T-Cell Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Led By Anjali S Advani

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a Zubrod performance status of 0-3

Patients must have creatinine clearance > 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial looks at how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. OBI-3424 may reduce the amount of leukemia in the body.

Who is the study for?

Adults diagnosed with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) who have at least 5% lymphoblasts in blood or bone marrow, and no central nervous system disease. They must be over 18, with adequate kidney and liver function, not pregnant or nursing, and willing to use contraception. Excluded are those recently receiving certain chemotherapies, post-allogeneic transplant patients within 90 days, individuals with uncontrolled infections or severe graft versus host disease.Check my eligibility

What is being tested?

The trial is testing OBI-3424's effectiveness for T-ALL that has returned after treatment or hasn't responded to it. OBI-3424 is a chemotherapy drug designed to kill cancer cells by preventing them from growing and spreading.See study design

What are the potential side effects?

While specific side effects of OBI-3424 aren't listed here, common side effects of chemotherapy drugs like this can include fatigue, nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts, and potential damage to organs such as the heart and kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do heavy physical work.

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My kidney function, measured by creatinine clearance, is good.

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I am 18 years old or older.

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My cancer did not respond or has returned after standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Response rate (complete remission [CR] or CR with incomplete count recovery [CRi])

Secondary outcome measures

Event-free survival

Incidence of adverse events

Overall survival

+1 more

Other outcome measures

AKR1C3 expression

Minimal residual disease (MRD) rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AKR1C3-activated prodrug OBI-3424)Experimental Treatment1 Intervention

Patients receive AKR1C3-activated prodrug OBI-3424 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

264,581 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,711 Total Patients Enrolled

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,222 Total Patients Enrolled

Media Library

OBI-3424 (Prodrug) Clinical Trial Eligibility Overview. Trial Name: NCT04315324 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Treatment (AKR1C3-activated prodrug OBI-3424)

Acute Lymphoblastic Leukemia Clinical Trial 2023: OBI-3424 Highlights & Side Effects. Trial Name: NCT04315324 — Phase 2

OBI-3424 (Prodrug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04315324 — Phase 2

Frequently Asked Questions

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

How many individuals are being given this treatment as part of the research?

"In order to carry out this trial, 39 patients that fit the inclusion criteria must enroll. These potential participants can be based in various locations, such as Henderson, Nevada and Las Vegas, Minnesota."

Answered by AI

Is this a new clinical trial?

"AKR1C3-activated Prodrug OBI-3424 has been under investigation since 2018, when the first study was completed with support from OBI Pharma, Inc. This initial study included 104 participants. After this Phase 1 & 2 trial showed success in 2018, there are now two active AKR1C3-activated Prodrug OBI-3424 trials taking place across 65 cities in a single country."

Answered by AI

What other scientific research has been conducted with AKR1C3-activated Prodrug OBI-3424?

"OBI-3424, a prodrug that is activated by AKR1C3, was first studied in 2018 at the Rutgers Cancer Institute of New jersey. Out of the total 2 active clinical trials, many are being conducted in Henderson, Nevada."

Answered by AI

In how many different medical clinics is this study being run today?

"Presently, this on-going clinical trial is being conducted out of GenesisCare USA - Henderson in Henderson, Nevada; 21st Century Oncology in Las Vegas, Minnesota; and GenesisCare USA - Las Vegas in Burnsville, Oregon. There are also 100 other sites running this study."

Answered by AI

Has the FDA given the green light to use AKR1C3-activated Prodrug OBI-3424?

"OBI-3424, which is currently in Phase 2 trials, has some safety data to support its use but no efficacy data. Therefore, it was given a score of 2."

Answered by AI

Are there any vacancies in this research for new participants?

"Indeed, the clinical trial is still ongoing and looking for 39 individuals at 100 different sites. The original posting was on 8/17/2020, with the most recent update being 11/9/2022 according to clinicaltrials.gov"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)

2021. "Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04315324.

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