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Refractory Acute Myeloid LeukemiaEarly Phase 1NCT03291353

Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia

A Early Phase 1 study testing pembrolizumab in people with Refractory Acute Myeloid Leukemia, run by Michael Boyiadzis at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open label, single-arm, pilot trial to evaluate the immune effects, safety and tolerability of pembrolizumab in subjects newly diagnosed with acute myeloid leukemia (AML) who have persistent leukemia after induction chemotherapy. Patients must have an ECOG performance status of 0-1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Acute Myeloid Leukemia
What is being tested?
pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
17 Oct 2017to 19 Aug 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be 18 years of age on the day of signing informed consent.
  • Patients with newly diagnosed AML based on the World Health Organization classification (21) who have persistent leukemia after a course or more of treatment with induction chemotherapy (the diagnosis of persistent disease, which is defined as >10% blasts by evaluation of bone marrow biopsy or bone marrow aspirate).
  • Left ventricular ejection fraction (LVEF) ≥ 45%
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.
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  • 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. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception- Contraception, for the course of the study through 120 days after the last dose of study medication.
  • Male subjects of childbearing potential must agree to use an adequate method of contraception- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Who cannot join

  • Has a diagnosis of Acute Promyelocytic Leukemia (APL) as defined by the World Health Organization
  • Relapsed acute myeloid leukemia
  • Bi-lineage or bi-phenotypic leukemias
  • Prior use of clofarabine or fludarabine
  • Previous allogeneic or autologous hematopoietic cell transplantation or solid organ transplantation
  • Is currently participating in and receiving study therapy, or has participated in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks of the first dose of treatment.
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  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • 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 (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Concurrent active malignancy; exceptions include patients who have been disease free for 5 years, patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or patients with another malignancy that is indolent or definitively treated.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or has known active central nervous system (CNS) leukemia involvement.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • 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, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • 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) (HIV 1/2 antibodies).
  • Has known active Hepatitis B or Hepatitis C.
  • Has received a live vaccine within 30 days of planned start of study therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

This is an open label, single-arm, pilot trial to evaluate the immune effects, safety and tolerability of pembrolizumab in subjects newly diagnosed with acute myeloid leukemia (AML) who have persistent leukemia after induction chemotherapy. Patients must have an ECOG performance status of 0-1. The enrollment target for this study is 10 patients.

Being tested
pembrolizumab
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabDrug

    Also called Keytruda

    200 mg IV given every three weeks

Study groups in NCT03291353
Study groupRoleWhat they receive
AML PatientsExperimentalpembrolizumab 200 mg given IV once every three weeks
Receives: Drug: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event assessment

    Adverse event assessment using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: From prior to first dose up to 48 months

Secondary outcomes (2)

  1. Response Rate (RR)

    The number of patients receiving treatment that experience either a Partial Response (remission) and/or a Complete Response (remission) / the total number of treated patients, per Response Criteria for Acute Leukemia criteria.

    Measured: Up to greater than or equal to 48 months

  2. Overall survival

    Median overall survival will be estimated by the Kaplan-Meier method with 90% confidence intervals.

    Measured: Up to greater than or equal to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start17 Oct 2017
  3. Primary completion19 Aug 2019 (estimated)
  4. Study completion19 Aug 2022 (estimated)

Why it stopped: This study has closed due to slow accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291353
Sponsor's protocol ID
17-056
Status last verified
Apr 2019
First submitted
19 Jun 2017
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing pembrolizumab in people with Refractory Acute Myeloid Leukemia, run by Michael Boyiadzis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event assessment (time frame: From prior to first dose up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.

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