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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: Completed Phase 2 study of Acute Myeloid Leukemia, in Relapse, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The rate of overall CR includes CR and CR with incomplete recovery (CRi) as defined by the International European LeukemiaNet Guidelines in AML. CR is defined as bone marrow blasts \<5%; absence of Auer rods; absence of extramedullary disease; absolute neutrophil count \>1,000/microliter (mcL); platelet count \>100,000/mcL; independence of red cell transfusions and CRi is defined as meeting all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL) plus ind
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-08-22 |
| Est. Completion | 2024-06-20 |
| Phase | Phase 2 |
What the finished NCT02768792 record still lists
NCT02768792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02768792's enrollment target sits among peer trials
38 8th of 16 higher than 9 of 16 other Acute Myeloid Leukemia, in Relapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia, in Relapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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