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Chronic Lymphocytic LeukemiaPhase 2PACE-CLLNCT05465876

Passive Antibodies Against COVID-19 With EVUSHELD in Vaccine Non-responsive CLL

A Phase 2 study testing EVUSHELD in people with Chronic Lymphocytic Leukemia and COVID-19, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Chronic lymphocytic leukaemia (CLL) is a common lymphoid malignancy affecting older adults. CLL patients are immunocompromised by the disease itself and by several of its therapies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia, COVID-19
What is being tested?
EVUSHELD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Oct 2023to Oct 2025
Phase
Phase 2
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

  • Have a diagnosis of CLL according to international working group CLL criteria
  • Treatment-naïve, post treatment or on-treatment for CLL
  • Male or female ≥ 18 years of age on day of signing informed consent
  • Weight ≥ 40 kg at the screening
  • Have received at least 2 standard of care SARS-CoV-2 vaccines within the last 18 months prior to enrolment. These vaccines may include all vaccines given in Canada since the beginning of the pandemic including: Pfizer BNT162b2 (COMIRNATY®), Moderna mRNA-1273 (SPIKEVAX®), and Astra Zeneca AZD1222 (Vaxzevria®)
  • Last SARS-CoV-2 vaccination ≥28 days ago and no more than 18 months ago.
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  • Participants must have a demonstrated absent or suboptimal response to standard of care SARS-CoV-2 vaccinations on screening bloodwork and will be prioritized for this study as they are deemed to be at higher risk of serious COVID-19 infection.
  • Have a performance status of 0-2 on the ECOG Performance Scale.
  • Have adequate organ function laboratory values, anytime during the screening period
  • Have a life expectancy > 6 months in the opinion of the referring hematologist.
  • Female subject of childbearing potential should have a negative serum pregnancy test prior to receiving study medication (study day 0).
  • Female participants of childbearing potential should be willing to use 2 highly effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the duration of the study (after signing consent) to prevent pregnancy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male participants should be surgically sterile or agree to use a highly effective method of contraception for the duration of the study (after signing consent) to prevent pregnancy in their partner.
  • Participants must agree to abstain from donating blood or plasma from the time of informed consent and for one year
  • Able and willing to provide signed informed consent for the trial
  • Ability to comply with protocol requirements.

Who cannot join

  • Signs and symptoms consistent with symptomatic COVID-19 illness within 30 days of consent.
  • Prior (within 30 days), current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment, or if clinically indicated as standard of care for a COVID-19 infection, should not be administered within 14 days of the EVUSHELD administration
  • Current infection requiring treatment with antibiotics or antifungals (not including prophylactic medications given with current therapy). Note: Participants completing a course of antibiotics for acute infection 7 days prior to SD0 and who do not experience a recurrence of symptoms or fever are eligible.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Has known psychiatric or substance abuse disorders that would interfere with adherence with the requirements of the trial.
  • Previous hypersensitivity reaction following administration of a monoclonal antibody
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  • Currently pregnant, lactating or breast feeding
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 21 days of treatment (SD0).
  • Receive a COVID-19 booster shot within 90 days of EVUSHELD administration
  • Known history of allergy to any component of the study drug formulation or its excipients
  • History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IV infusions or venipuncture.
  • Any other significant disease, disorder, or finding that may; significantly increase the risk to the participant because of participation in the study; affect the ability of the subject to participate in the study; or impair interpretation of the study data.
  • Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to enrollment.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Cente

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Multi-Center, Open-Label, Single-Arm Phase II Trial of Antibody Combination EVUSHELD (Tixagevimab and Cilgavimab) to Provide Passive Immunity Against COVID-19 in Vaccine Non-responsive Chronic Lymphocytic Leukemia

Chronic lymphocytic leukaemia (CLL) is a common lymphoid malignancy affecting older adults. CLL patients are immunocompromised by the disease itself and by several of its therapies. It has now been shown that many CLL patients do not mount an antibody response following COVID-19 vaccination and are therefore at risk of COVID-19 infection. Furthermore, patients with hematologic malignancies are known to be at increased risk of severe infection if they do acquire COVID-19 infection.

The purpose of this trial is to document evidence of passive immunity to COVID-19 infection after EVUSHELD administration with serologic and neutralization assays at multiple post administration time points in patients with no response to standard of care vaccination to COVID-19.

Read more

This trial will include a single dose of EVUSHELD to be administered, with a 1-year follow-up period, comprising of 8 health status visits.

Blood samples will be taken at screening, baseline and at multiple health status visits over the course of the year for various antibody testing and analysis. T cell reactivity to COVID-19 epitopes will be studied at baseline and again monthly for 3 months in any participants that become infected with COVID-19.

Being tested
EVUSHELD
Keywords
EVUSHELD
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, COVID-19

What participants receive

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

  • EVUSHELDBiological

    EVUSHELD is a combination of 2 monoclonal antibodies (mAbs), Tixagevimab and Cilgavimab. The single dose, is to be administered intramuscular, each mAb sequentially into the deltoid

Study groups in NCT05465876
Study groupRoleWhat they receive
EVUSHELDExperimentalNot described
Receives: Biological: EVUSHELD

What is being measured

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

  1. Passive Immunity

    The primary study objective is to confer passive immunity to CLL patients, so the primary outcome measurement is the proportion of of participants after EVUSHELD administration with anti-spike antibodies above the minimal level set as a standard for convalescent serum or 210 u/ml using the Roche assay

    Measured: 12 months

Secondary outcomes (8)

  1. Surrogate Viral Neutralization Assay

    Serum neutralization using a surrogate viral neutralization assay levels (representing levels of EVUSHELD) at months 1-6, 9 and 12 to document longevity of protection following one-time administration of the product.

    Measured: 12 months

  2. Pseudo- Viral Naturalization Assay

    Serum neutralization with a pseudo-typed viral-like particle (pseudo-virus) neutralization assay will be completed using samples obtained from 50% of participants (i.e. 25) within each treatment group at baseline and five post treatment time points. These results will be modeled over the course of the study.

    Measured: 12 months

  3. Pharmacokinetic Assessments

    Serum pharmacokinetic levels of antibodies to the COVID-19 RBD epitope at the baseline visit and visits 1, 3, 5, 7, and 8 to provide additional supportive data documenting longevity of protection following one-time administration of the product (in a subset of patients)

    Measured: 12 months

  4. COVID-19 Infection (antibodies)

    COVID-19 infection as documented by evidence of antibodies to the nucleocapsid (NC) protein

    Measured: 12 months

  5. COVID-19 Infection (RAT/PCR)

    COVID-19 infection documented by PCR or RAT.

    Measured: 12 months

  6. Symptomatic COVID-19 infection

    Symptomatic COVID-19 infection and outcomes as documented by participant clinical symptomatology and status (hospital admission, ICU admission, or death) at conclusion of the trial

    Measured: 12 months

  7. Safety of EVUSHELD

    Safety will be evaluated at each clinical visit and will include the documentation of; any changes in grade/seriousness or severity of baseline medical history, body temperature, blood pressure, oxygen saturation, heart rate, pulse, and review of symptoms, toxicities at monthly time points. Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v5.0).

    Measured: 12 months

  8. Baseline T cell responses to COVID-19 as a potential predictor of breakthrough COVID-19 infections

    T cell responses at baseline will be evaluated by COVID-19-specific LEGEND-plex cytokine detection with stratification according to participant treatment group to help understand mechanisms of viral escape in participants who do become infected with COVID after EVUSHELD administration.

    Measured: 12 months

Timeline

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

  1. First posted20 Jul 2022
  2. Study startOct 2023 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Why it stopped: Funding pulled

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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective multi-centre open-label investigator-initiated single arm descriptive phase 2 clinical trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05465876
Sponsor's protocol ID
3989
Acronym
PACE-CLL
Status last verified
Apr 2024
First submitted
18 Jul 2022
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EVUSHELD in people with Chronic Lymphocytic Leukemia and COVID-19, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 16 inclusion and 13 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 4 Apr 2024. 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 Canada. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Passive Immunity (time frame: 12 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 NCT05465876.

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 4 Apr 2024.

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