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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 with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection)
Patients must have a Zubrod performance status of 0-3
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 have chronic hepatitis B but my viral load is undetectable or I am on treatment.
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I can take care of myself but may not be able to do heavy physical work.
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I haven't had nelarabine therapy, and my doctor thinks other treatments won't work for me.
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My kidney function, measured by creatinine clearance, is good.
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I have no signs of brain or spinal cord disease recently.
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I have HIV, am on effective treatment, and my last viral load was undetectable.
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I have relapsed or refractory T-cell acute lymphoblastic leukemia.
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My liver enzymes are within the acceptable range for the trial.
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I am 18 years old or older.
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I have acute leukemia with at least 5% lymphoblasts in my blood or bone marrow.
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I have hepatitis C but my viral load is undetectable or I am on treatment.
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My cancer did not respond or has returned after standard treatment.

Timeline

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,596 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,571 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,212 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
~17 spots leftby Aug 2026