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NCT02768792 · ClinicalTrials.gov registry record · Phase 2

High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML

A Phase 2 study of Acute Myeloid Leukemia, in Relapse, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
2
Study locations

NCT02768792 is a Phase 2 study of Acute Myeloid Leukemia, in Relapse that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 38 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT02768792, a Phase 2 study of Acute Myeloid Leukemia, in Relapse, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
2
Study locations

Study Summary

Rationale:The purpose of this research study is to test the effectiveness of the standard high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab on day 14 as induction therapy in patients with relapsed and refractory acute myeloid leukemia (AML). Patients who achieve a response to treatment will continue on the study drug (pembrolizumab) every 3 weeks for up to 2 years maintenance therapy. Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed and refractory AML. The study will also explore the association between potential immune biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood and bone marrow samples collected before and after treatment to determine the dynamic nature of immune signatures pre and post-treatment.

Conditions Studied

Acute Myeloid Leukemia, in Relapse

Interventions

  • DRUG pembrolizumab,

Study Locations (2)

Maryland

  • Johns Hopkins School of Medicine The Sidney Kimmel Comprehensive Cancer Center - Baltimore

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2016-08-22
Est. Completion 2024-06-20
Phase Phase 2

Sponsor

UNC Lineberger Comprehensive Cancer Center

366 total trials

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What the Registry Record Tells You About NCT02768792

The ClinicalTrials.gov registry entry for NCT02768792 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (33% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 1 intervention - of which pembrolizumab, is the first listed.

NCT02768792 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT02768792 about?

NCT02768792 is a clinical study titled "High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML". Rationale:The purpose of this research study is to test the effectiveness of the standard high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab on day 14 as induction therapy in patients with relapsed and refractory acute myeloid leukemia (AML). Patients who ach...

What is the current status of trial NCT02768792?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2016-08-22. Estimated completion is 2024-06-20.

What conditions does trial NCT02768792 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, in Relapse.

What interventions are being tested in trial NCT02768792?

The interventions under investigation include: pembrolizumab, (DRUG).

Who is sponsoring clinical trial NCT02768792?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02768792 being conducted?

This trial has 2 study locations across Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.