Augmentation of the Graft vs. Leukemia Effect Via Checkpoint Blockade With Pembrolizumab

  • STATUS
    Recruiting
  • End date
    Nov 23, 2022
  • participants needed
    20
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 23 April 2022
cancer
myeloid leukemia
lymphoid leukemia
leukemia
bone marrow procedure

Summary

This is a single arm, open-label, Phase 1b study of pembrolizumab for patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) whose disease has relapsed after receiving allogeneic hematopoetic stem cell transplant.

Details
Condition Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Treatment Pembrolizumab
Clinical Study IdentifierNCT03286114
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS) in confirmed relapse
Confirmation of 'measurable disease'
Patient may not have received definitive salvage chemotherapy for their post-transplant relapse within the past 21 days
Be willing and able to provide written informed consent/assent for the trial
Be ≥ 18 years of age on day of signing informed consent
Be willing to provide tissue from bone marrow biopsies
Have a performance status of 0, to 1 on the ECOG Performance Scale. Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death
Demonstrate adequate organ function
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication
Female subjects of childbearing potential must be willing to use an adequate method of contraception
Male subjects of childbearing potential must agree to use an adequate method of contraception

Exclusion Criteria

Has had relapse prior to primary neutrophil engraftment or ≤21 days post HCT
Has received >1 line of chemotherapy or other treatment directed towards post-transplant relapse prior to study entry
Rapidly progressive relapse requiring urgent chemotherapy as determined by treating physician
Is currently participating and receiving study therapy of an investigational agent and received study therapy within 2 weeks of the first dose of treatment
Has a diagnosis of active GvHD (≥ Grade I)
Receiving systemic steroid therapy of > 10mg prednisone daily or equivalent
Has received GM-CSF within 14 days of first dose of pembrolizumab
Has a known history of active TB (Bacillus Tuberculosis)Hypersensitivity to pembrolizumab or any of its excipients
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered from adverse events
Has had prior chemotherapy within 21 days or radiation therapy within 14 days prior to study Day 1 or who has not recovered from adverse events
Has a known additional (secondary) malignancy that is progressing or requires active treatment
Has known or suspected active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Has a known history of Human Immunodeficiency Virus (HIV)
Has known active Hepatitis B or Hepatitis C
Has received a live vaccine within 30 days of planned start of study therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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