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Hormone Therapy

Nerofe for Acute Myeloid Leukemia

Phase 1
Recruiting
Research Sponsored by Immune System Key Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year.
Awards & highlights

Study Summary

This trial is testing a new drug, NEROFE, to see if it is safe and effective in treating patients with MDS or AML. NEROFE will be given intravenously three times per week, and the dosage will be based on the patient's weight.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients
Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.
Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NEROFEExperimental Treatment1 Intervention
Dose Level - Nerofe Dose -1 - 6mg/m2 - 12 mg/m2 - 24 mg/m2 - 48 mg/m2 - 96 mg/m2 - 150mg/m2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nerofe
2013
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Immune System Key LtdLead Sponsor
4 Previous Clinical Trials
47 Total Patients Enrolled
University of Miami Sylvester Comprehensive Cancer CenterOTHER
9 Previous Clinical Trials
2,601 Total Patients Enrolled

Frequently Asked Questions

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

Is there still an opportunity to register for this investigation?

"Affirmative. According to information stored on clinicaltrials.gov, this medical research is actively seeking participants with the original post date of June 18th 2020 and most recent edit made on July 21st 2022. The trial has a goal of recruiting 18 patients from 1 site."

Answered by AI

What is the participant capacity for this clinical research?

"Affirmative. The clinicaltrials.gov database conveys that this trial is presently recruiting volunteers, with the initial posting date being June 18th 2020 and the last update occurring on July 21st 2022. Researchers seek to recruit 18 participants from one medical facility."

Answered by AI

Is this experiential research pioneering a new approach?

"Presently, only one active clinical trial for Nerofe is running in 1 city and country. Initially run by Immune System Key Ltd in 2020, this Phase 1 drug approval process enrolled 18 patients and completed successfully. Since then, no other trials have been conducted."

Answered by AI

Are there any other trials that have been conducted utilizing Nerofe?

"Presently, there is one operational clinical investigation for Nerofe with no Phase 3 trials. This research has a hub in Miami, Florida and an additional location conducting experiments."

Answered by AI

Has Nerofe been accorded official authorization by the FDA?

"With limited evidence to suggest its efficacy and safety, Nerofe has been assigned a rating of 1 by our team at Power."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
2020. "Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04365179.
~4 spots leftby May 2025
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