A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With AML
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|ClinicalTrials.gov Identifier: NCT02708641|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2016
Last Update Posted : May 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With Acute Myeloid Leukemia (AML) Who Are Not Transplantation Candidates|
|Actual Study Start Date :||October 4, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: AML patients
pembrolizumab 200 mg given IV once every three weeks
200 mg IV given every three weeks
Other Name: Keytruda
- Time to Relapse (TTR) [ Time Frame: Up to 24 months ]Time to recurrence of AML, including only deaths related to recurrence. Relapse of AML is defined as patients reaching remission (bone marrow contains <5% blast cells, blood cell counts return to within normal limits, no signs disease) followed by a return of leukemia cells in the marrow and a decrease in normal blood cells.
- Adverse Events Related to Treatment [ Time Frame: Up to 24 months ]Type and grade of Adverse Events possibly, probably or definitely related to treatment, per Common Terminology Criteria for Adverse Events CTCAE v4.0
- Overall Survival (OS) [ Time Frame: Up to 48 months ]The length of time from date of start of treatment that patients are still alive.
- Quantification of activated T cells [ Time Frame: Up to 24 months ]Determination of activated T cells level (percentages) in peripheral blood. Increased levels of activated T cells may indicate decreasing disease progression.
- Quantification of activated NK cells [ Time Frame: Up to 24 months ]Determination of activated NK cells level (percentages) in peripheral blood. Increased levels of activated T cells may indicate decreasing disease progression.
- Quantification of regulatory T cells (Treg) [ Time Frame: Up to 24 months ]Determination of regulatory T cell (Treg) levels (percentages) in peripheral blood. Treg cells are involved in cancer progression by inhibiting anti-cancer immunity. Increased levels of Treg cells may indicate progressing disease.
- Cytokine expression [ Time Frame: Up to 24 months ]Determination of cytokine expression levels (percentages) in peripheral blood. Cytokine expression is associated with cancer progression, immuno-suppression, and decreased anti-cancer response.
- Granzyme B/perforin expression [ Time Frame: Up to 24 months ]
Determination of Granzyme B/perforin expression levels (percentages) in peripheral blood.
Granzyme B/perforin expression is associated with the suppression of cancer progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708641
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Michael Boyiadzis, MD, MHSc||UPMC Hillman Cancer Center|