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Anti-metabolites

Cytarabine + Pembrolizumab for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Joshua F Zeidner, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged > 18 and < 70 years on day of signing informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of treatment up to 7 years of follow-up (with a median of 7.8 months of follow-up at time of reporting)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat relapsed and refractory AML. The new drug is called pembrolizumab and it will be given with standard chemotherapy. The study will also explore how well the new drug works and if it has any side effects.

Who is the study for?
Adults aged 18-70 with relapsed or refractory acute myeloid leukemia (AML) who've had at least one cycle of induction therapy can join. They must be in good physical condition, not pregnant, willing to use contraception, and have normal organ function. People with immune deficiencies, active infections like TB or hepatitis, autoimmune diseases requiring recent treatment, or those on immunosuppressive drugs cannot participate.Check my eligibility
What is being tested?
The trial tests high dose cytarabine chemotherapy followed by pembrolizumab (an investigational drug) for AML that has come back or didn't respond to other treatments. Participants will receive this combination as an initial therapy and may continue pembrolizumab every three weeks for up to two years if they respond well.See study design
What are the potential side effects?
Pembrolizumab might cause immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), skin reactions, hormone gland problems (like thyroid disorders), and changes in liver enzymes which could indicate liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I am fully active or can carry out light work.
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My AML has returned, with more than 5% cancer cells in my bone marrow.
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I have received initial treatment for acute myeloid leukemia.
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I am a man and I agree to use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of treatment up to 7 years of follow-up (with a median of 7.8 months of follow-up at time of reporting)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of treatment up to 7 years of follow-up (with a median of 7.8 months of follow-up at time of reporting) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Rate of Complete Remission (CR)
Secondary outcome measures
Median Overall Survival (OS) of Patients Who Received Induction Phase of Treatment.
Median Progression-free Survival (PFS) of Patients Receiving Maintenance Pembrolizumab.
Median Relapse-free Survival (RFS) of Patients Receiving Maintenance Pembrolizumab
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: open-label, multicenter, single-armExperimental Treatment1 Intervention
Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of HiDAC salvage induction chemotherapy. Patients who have a response (i.e., PR/CR/CRi) to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2-years of maintenance therapy (i.e., beginning on day 1 of maintenance). Patients who are ineligible for pembrolizumab administration by day 21 will be removed from the study.

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Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,936 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,294 Total Patients Enrolled
Joshua F Zeidner, MDPrincipal InvestigatorLineberger Comprehensive Cancer Center University of North Carolina

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02768792 — Phase 2
Acute Myeloid Leukemia Research Study Groups: open-label, multicenter, single-arm
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT02768792 — Phase 2
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02768792 — Phase 2

Frequently Asked Questions

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

What safety measures have been implemented to ensure this therapy is secure for use?

"Since this is an early-phase trial, and there are only limited safety data available but none regarding efficacy, the treatment was given a score of 2."

Answered by AI

Is this experimentation open to participants 40 years or older?

"Enrolment in this experiment is limited to individuals aged 18 or over, with a maximum age of 70."

Answered by AI

Could you provide an overview of other trials that have tested this therapeutic intervention?

"This treatment was first examined a decade ago at City of Hope. To date, there has been an accumulation of 249 completed trials and 961 ongoing experiments; many are taking place in Chapel Hill, North carolina."

Answered by AI

What is the highest participant count for this research endeavor?

"At the moment, no further recruitment is taking place for this trial. It was originally published on August 22nd 2016, and last edited on August 10th 2022. An abundance of other clinical trials are searching for participants - there are 1463 studies actively seeking patients with leukemia, as well as 961 more that aim to treat it effectively."

Answered by AI

Are there still opportunities for participants to join this experiment?

"As reported on clinicaltrials.gov, this medical study is no longer accepting new patients. The initial post was August 22nd 2016 and the last update was August 10th 2022; however, there are presently 2,424 other trials in progress that require participants."

Answered by AI

What primary conditions is this intervention typically used to treat?

"This treatment has been shown to be efficacious against malignant neoplasms, unresectable melanoma, and conditions of microsatellite instability high."

Answered by AI

Who would be eligible to participate in this clinical research project?

"This clinical trial requires participants to be between ages 18 and 70, with a diagnosis of leukemia. Currently, 38 patients are sought after for this research opportunity."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
2016. "High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02768792.
~4 spots leftby Apr 2025
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