What side effects are associated with this type of intervention?

The most common treatments for Acute Promyelocytic Leukemia (APL) include all-trans retinoic acid (ATRA) and arsenic trioxide. These treatments are generally effective but come with several side effects. ATRA can cause differentiation syndrome, characterized by fever, weight gain, respiratory distress, and fluid retention. Arsenic trioxide may lead to QT prolongation, which can cause serious heart rhythm problems, as well as symptoms like fatigue, nausea, and peripheral neuropathy. Both treatments can also cause general side effects such as leukocytosis, liver function abnormalities, and electrolyte imbalances. Close monitoring and supportive care are essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) for the treatment of Acute Promyelocytic Leukemia (APL). These drugs target the PML-RARA fusion protein, a key driver in APL. ATRA promotes the differentiation of leukemic cells, while ATO induces apoptosis and degradation of the PML-RARA oncoprotein. These treatments have significantly improved patient outcomes. The trial NRX 195183 likely involves a similar mechanism, focusing on pathways specific to APL.

What other types of research exist?

Based on the provided context, there are no specific novel alternatives to NRX 195183 mentioned for Acute Promyelocytic Leukemia. However, patients should discuss with their healthcare provider about ongoing clinical trials and emerging therapies targeting the PML-RARA fusion protein or related pathways, as these may offer new treatment options in 2024.

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NRX 195183 for Acute Promyelocytic Leukemia

Phase 2

Waitlist Available

Research Sponsored by NuRx Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation

Relapse from, resistance to, or intolerance of ATRA, cytotoxic chemotherapy, or arsenic trioxide

Must not have

Non-APL, AML patients

Other serious illnesses limiting survival to 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NRX 195183 to see if it can help patients with a type of leukemia who have not responded to other treatments. These patients have very few options left, so finding an effective treatment is very important.

Who is the study for?

This trial is for adults with relapsed or refractory Acute Promyelocytic Leukemia confirmed by specific tests. Participants must have normal bilirubin and creatinine levels, not be pregnant or nursing, and willing to use birth control. Excluded are those with non-APL AML, severe heart disease, AIDS/HIV, other life-limiting illnesses, or psychiatric conditions affecting treatment compliance.

What is being tested?

The study is testing the effectiveness of NRX 195183 Soft Gelatin Capsule in treating Acute Promyelocytic Leukemia that has returned after or resisted standard treatments like chemotherapy.

What are the potential side effects?

While specific side effects of NRX 195183 aren't listed here, similar leukemia treatments can cause fatigue, nausea, bleeding issues, infections due to low blood cell counts and potential harm to an unborn child if taken during pregnancy.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia has a specific genetic feature confirmed by tests.

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My condition worsened or didn't tolerate previous treatments including ATRA, chemotherapy, or arsenic trioxide.

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I am 18 years old or older.

Exclusion Criteria

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

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I have AML that is not the APL subtype.

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I do not have any illnesses that limit my life expectancy to 6 months.

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I do not have severe heart problems like recent heart attacks or uncontrolled heart failure.

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I am HIV positive or have AIDS.

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

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: 1Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Promyelocytic Leukemia (APL) include all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). These treatments work by targeting the PML-RARA fusion protein, a hallmark of APL, which blocks the differentiation of myeloid cells. ATRA binds to the RARA portion of the fusion protein, promoting the degradation of PML-RARA and allowing the cells to mature and die naturally. ATO induces the degradation of the PML-RARA protein through oxidative stress and apoptosis. These mechanisms are crucial for APL patients as they directly address the underlying genetic abnormality, leading to high remission rates. Treatments like NRX 195183 likely operate through similar pathways, targeting specific molecular abnormalities in APL to restore normal cell function and improve patient outcomes.