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Trial record 1 of 1 for:    NCT02708641
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A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708641
Recruitment Status : Active, not recruiting
First Posted : March 15, 2016
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Boyiadzis, University of Pittsburgh

Brief Summary:
This is a phase II study to evaluate the effect of pembrolizumab on the duration of remission in acute myeloid leukemia. Pembrolizumab is given after complete remission is obtained in those with AML at least 60 years old who are not candidates for allogeneic stem cell transplant. The primary purpose of this study is determine if the time to relapse can be extended. Additionally, the safety and tolerability of pembrolizumab will be closely monitored.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: AML patients
pembrolizumab 200 mg given IV once every three weeks
Drug: pembrolizumab
200 mg IV given every three weeks
Other Name: Keytruda




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 48 months ]
    The length of time from date of start of treatment that patients are still alive.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be willing and able to provide written informed consent for the trial
  • be ≥ 60 years of age on day of signing informed consent
  • have a newly diagnosed AML based on the World Health Organization (WHO) criteria, currently in first complete remission (CR) on a bone marrow biopsy performed within 4 weeks of treatment initiation
  • have received the last dose of induction or consolidation chemotherapy within 3 months of treatment initiation
  • not be eligible for or willing to proceed with allogeneic stem cell transplant or for whom allogeneic stem cell transplant is not considered standard of care
  • have a performance status of ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • demonstrate adequate organ function, with all screening labs performed within 10 days of treatment initiation
  • transfusion independent (no red blood cell or platelet transfusions in the preceding 2 weeks of screening)
  • negative urine and/or serum pregnancy test
  • subjects of reproductive potential must agree to use acceptable birth control method

Exclusion Criteria:

  • have a diagnosis of Acute Promyelocytic Leukemia (APL) as defined by the WHO
  • currently participating in or has participated in a study of an investigational agent or device within 4 weeks of treatment initiation
  • have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to treatment initiation
  • have prior monoclonal antibody within 4 weeks prior to study Day 1 or have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • have prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 have not recovered from adverse events due to previously administered agent(s)
  • have a known additional malignancy that is progressing or requires active treatment except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
  • have known active central nervous system (CNS) involvement
  • have an active autoimmune disease requiring systemic treatment within the past 3 months
  • has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • have an uncontrolled, life-threatening active infection
  • have a history or current evidence of condition, therapy, or laboratory abnormality that would preclude study participation in the opinion of the treating investigator
  • have known psychiatric or substance abuse disorders that would interfere with cooperation with the trial requirements
  • is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
  • have received prior therapy with any antibody targeting the T-cell co-stimulation or checkpoint pathways
  • have a known history of HIV
  • have known active Hepatitis B or Hepatitis C
  • have received a live vaccine within 30 days prior to treatment initiation

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Michael Boyiadzis
Investigators
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Principal Investigator: Michael Boyiadzis, MD, MHSc UPMC Hillman Cancer Center
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Responsible Party: Michael Boyiadzis, Associate Professor of Medicine, Division of Hematology Oncology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02708641    
Other Study ID Numbers: 15-101
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents