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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

Must not have

Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration

Patients must have no evidence of >= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD and must have no history of extensive GVHD of any severity within 90 days prior to registration. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an uncontrolled infection.

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I haven't had severe reactions from a transplant in the last 3 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Event-free survival

Incidence of adverse events

Overall survival

+1 more

Other study objectives

AKR1C3 expression

Minimal residual disease (MRD) rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met