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

Frequently Asked Questions

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

What are the risks associated with NRX 195183 Soft Gelatin Capsule?

"NRX 195183 Soft Gelatin Capsule is being assessed as a potential new medication, so it received a score of 2. This is because while there is data supporting its safety, there is none yet backing up its efficacy."

Answered by AI

Could you tell me how many people are enrolled in this experiment?

"Presently, this study is not seeking any more participants. It was originally posted on April 1st, 2008 and last updated on May 9th, 2008. However, there are 1462 other trials for leukemia patients and 5 for NRX 195183 Soft Gelatin Capsule that are still looking for individuals to enroll."

Answered by AI

To your knowledge, does a similar trial exist?

"NRX 195183 Soft Gelatin Capsule has a long research history, with the first study being conducted in 2008. The Phase 2 drug approval was received after the initial 65-person trial that was sponsored by NuRx Pharmaceuticals, Inc. Now, 5 live studies are ongoing across 6 cities and 1 nation."

Answered by AI

Could you please share any similar research to NRX 195183 Soft Gelatin Capsule?

"As of now, there are 5 ongoing clinical trials for NRX 195183 Soft Gelatin Capsule with 1 in Phase 3. Even though a plurality of the research is based in Seattle, 8 different locations are running these sorts of studies."

Answered by AI

Are new participants being sought for this trial?

"According to the listing on clinicaltrials.gov, this study is no longer recruiting patients for participation. The trial was first posted on April 1st, 2008 and was last updated on May 9th, 2008. There are many other trials (1467 at present) that may be a better match for individuals looking to get involved in research studies."

Answered by AI
~4 spots leftby Mar 2025