Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-20 @ 5:48 PM
Study NCT ID:
NCT02768792
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2016-05-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
LCCC 1522: Phase 2 Study of High Dose Cytarabine Followed by Pembrolizumab in Relapsed and Refractory Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Primary Objective
1\. Estimate the objective overall rate of CR (CR+CRi) for age-adjusted HiDAC (age \<60 years: 2 gm/m2 IV Q12hours days 1-5; age \>60 years: 1.5 gm/m2 IV Q12hours days 1-5) followed by pembrolizumab 200 mg IV on day 14 in relapsed and refractory AML patients
Secondary Objectives
1. Estimate the rate of unacceptable toxicity associated with HiDAC followed by pembrolizumab as induction therapy
2. Estimate the objective overall response rates (PR+CR+CRi) for HiDAC followed by pembrolizumab.
3. Characterize the toxicity associated with HiDAC followed by pembrolizumab as induction therapy
4. Characterize the toxicity associated with pembrolizumab 200 mg IV Q3weeks when used as monotherapy maintenance after an initial response to induction phase HiDAC followed by pembrolizumab
5. Estimate the relapse-free survival (RFS) and progression-free survival (PFS) of patients receiving maintenance pembrolizumab
6. Estimate the overall survival (OS) of patients who received induction phase treatment.
1\. Estimate the objective overall rate of CR (CR+CRi) for age-adjusted HiDAC (age \<60 years: 2 gm/m2 IV Q12hours days 1-5; age \>60 years: 1.5 gm/m2 IV Q12hours days 1-5) followed by pembrolizumab 200 mg IV on day 14 in relapsed and refractory AML patients
Secondary Objectives
1. Estimate the rate of unacceptable toxicity associated with HiDAC followed by pembrolizumab as induction therapy
2. Estimate the objective overall response rates (PR+CR+CRi) for HiDAC followed by pembrolizumab.
3. Characterize the toxicity associated with HiDAC followed by pembrolizumab as induction therapy
4. Characterize the toxicity associated with pembrolizumab 200 mg IV Q3weeks when used as monotherapy maintenance after an initial response to induction phase HiDAC followed by pembrolizumab
5. Estimate the relapse-free survival (RFS) and progression-free survival (PFS) of patients receiving maintenance pembrolizumab
6. Estimate the overall survival (OS) of patients who received induction phase treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: