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Anti-metabolites

Melphalan for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Scott Solomon, MD
Research Sponsored by Northside Hospital, Inc.
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 2 years
Awards & highlights

Study Summary

This trial is testing if a new immunotherapy can help patients with a type of leukemia that are not candidates for stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With 2-year Relapse Risk
Secondary outcome measures
Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lymphodepletion plus PembrolizumabExperimental Treatment3 Interventions
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,071 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,533 Total Patients Enrolled
Scott Solomon, MDPrincipal InvestigatorBlood and Marrow Transplant Group of Georgia
6 Previous Clinical Trials
20,232 Total Patients Enrolled

Frequently Asked Questions

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

To what ailments is Pembrolizumab usually given as a treatment?

"Pembrolizumab is the most commonly prescribed treatment for unresectable melanoma and can also be beneficial in managing microsatellite instability high, reducing recurrence risk, or controlling disease progression."

Answered by AI

Are there any opportunities for individuals to participate in this research endeavor?

"This clinical study has ended its recruitment phase, with the primary posting on September 28th 2016 and last edit being made on September 7th 2022. However, for those interested in other trials related to leukemia, myelocytic or acute diseases there are 507 studies currently running while 1393 participants can join Pembrolizumab's trial."

Answered by AI

Has research into the effects of Pembrolizumab been conducted previously?

"Currently, 1393 trials involving Pembrolizumab are running. Of those experiments, 159 have reached the third stage of testing. Although Scottsdale, Arizona is home to most clinical trials for this medication, there are an additional 41020 sites also hosting research studies."

Answered by AI

What potential hazards should be considered when using Pembrolizumab?

"Our research team at Power has assigned a score of 2 to Pembrolizumab's safety, as this is still in the Phase 2 trial stage and there are data points suggesting its security but not yet indicating efficacy."

Answered by AI

Is there an age restriction for participation in this clinical trial?

"The qualifications for this trial state that the minimum age to enroll is 18, while the maximum age permitted is 78."

Answered by AI

What criteria must one meet to be considered eligible for enrollment in this trial?

"This clinical trial is in search of 20 participants between 18 and 78 years old dealing with the diagnosis of non-favorable risk acute myelocytic leukemia. Additionally, applicants must be in remission or have achieved a prior complete response (CR) to qualify for enrollment."

Answered by AI

What is the enrollment capacity of this clinical trial?

"This trial is no longer acceptiong patients. It was first announced on September 28th, 2016 and its last update was on Septmeber 7th, 2022. If you are searching for other trials in the same area of research, 507 studies with acute myelocytic leukemia as an indication are open to participation and 1393 studies that utilize Pembrolizumab have available vacancies."

Answered by AI
Recent research and studies
~2 spots leftby Apr 2025