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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial is testing a new drug to treat people with a certain type of leukemia who have relapsed or who haven't responded to other treatments.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Remission
Secondary outcome measures
Molecular Complete Remission

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

NuRx Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

NRX 195183 Soft Gelatin Capsule (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00675870 — Phase 2
Acute Promyelocytic Leukemia Research Study Groups: 1
Acute Promyelocytic Leukemia Clinical Trial 2023: NRX 195183 Soft Gelatin Capsule Highlights & Side Effects. Trial Name: NCT00675870 — Phase 2
NRX 195183 Soft Gelatin Capsule (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00675870 — Phase 2
~4 spots leftby May 2025
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