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Large Granular Lymphocyte LeukemiaEarly Phase 1NCT05316116

Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

A Early Phase 1 study testing Siltuximab in people with Large Granular Lymphocyte Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the safety and effectiveness of siltuximab for participants being treated for large granular lymphocytic leukemia (LGLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large Granular Lymphocyte Leukemia
What is being tested?
Siltuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
15 Feb 2023to 18 Oct 2024
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

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged >/= 18.
  • Meet the diagnosis criteria of LGLL as below:
  • a. For a patient with treatment-naive LGLL, peripheral blood needs to have CD3+ CD57+ cells >400/mm³ or CD8+ cells >650/mm³, and, evidence for clonal T cell receptor gamma or beta gene rearrangement by PCR needs to be detected in either peripheral blood or bone marrow.
  • b. For patients with an established diagnosis of LGLL who have been previously treated, multicolor flow cytometry should identify a residual CD3+CD57+CD8+ LGLL population in peripheral blood or bone marrow, and, evidence for clonal T cell receptor gamma or beta gene rearrangement by PCR needs to be detected in either peripheral blood or bone marrow. There is no requirement that peripheral blood absolute clonal CD3+ CD57+ or CD8+ LGLL populations need to reach predetermined minimal value for eligibility since immunosuppressive therapy can significantly decrease LGLL cell count without any impact on neutropenia, anemia or thrombocytopenia which are major causes of morbidity and mortality
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  • Has at least one of the indications for treatment:
  • severe neutropenia less than 500/mm³, OR
  • neutropenia associated with recurrent infection, OR
  • symptomatic anemia with Hemoglobin < 9 g/dL, OR
  • transfusion-dependent anemia with transfusion needs >= 1 u per month, OR
  • severe thrombocytopenia <20,000/mm³, OR
  • thrombocytopenia <50,000/mm³ with bleeding.
  • Participant can be treatment-naïve or previously treated for LGLL.
  • Participant currently receiving therapy must have a wash-out period of ≥ 30 days or 5 elimination half-lives, whichever is longer, prior to study drug administration.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Creatinine clearance (CLCr) ≥15 mL/min.
  • If a participant has chronic liver disease, Child-Pugh score needs to be either A or B.
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to study drug infusion and agreement to use highly effective contraception during study participation and for an additional 3 months after the last dose of study drug.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose of study drug. Men must agree to not donate sperm during the same period.

Who cannot join

  • Any active infection requiring systemic therapy, including viral infections such as HIV, Hepatitis B, and/or Hepatitis C.
  • Current use of methotrexate, cyclophosphamide, or cyclosporine for any medical conditions.
  • Has coexisting myelodysplastic syndrome (MDS).
  • Elevated LGL due to viral infection.
  • Pregnancy or lactation.
  • Known severe allergic reactions to siltuximab.
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  • At increased risk for Gastrointestinal (GI) perforation, in the opinion of the study investigator.
  • Received live vaccine 30 days prior to study drug administration or Intend to receive live vaccine during treatment period and within 3 months after last dose of study drug.
  • Rheumatological conditions such as rheumatoid arthritis (RA) are not exclusion criteria for the study.
  • Coexisting hematological conditions such as autoimmune hematological anemia (AIHA) or immune thrombocytopenia (ITP) are not automatic exclusion criteria but will be at discretion of study investigator.
  • Previous or concurrent malignancies not considered cured, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, early-stage prostate cancer, or other cancer deemed clinically insignificant by the Investigator.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the study Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Pilot Study of Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

The purpose of the study is to evaluate the safety and effectiveness of siltuximab for participants being treated for large granular lymphocytic leukemia (LGLL).

Being tested
Siltuximab
Medical subject headings
Leukemia, Large Granular Lymphocytic

What participants receive

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

  • SiltuximabDrug

    Also called Interleukin-6

    Siltuximab will be given on day 1 of each cycle. The dose will be 11 mg/kg given over 1 hour by intravenous infusion. Each cycle is three weeks (+-3 days).

Study groups in NCT05316116
Study groupRoleWhat they receive
SiltuximabExperimentalSiltuximab will be given every 3 weeks, for between 18 and 36 weeks
Receives: Drug: Siltuximab

What is being measured

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

  1. Overall Response Rate

    Overall response rate is defined as the rate of achieving best response of CR or PR, and will be summarized for participants who have received any dose of study drug

    Measured: Up to 30 months

Secondary outcomes (7)

  1. Complete Response Rate (CR)

    CR rate is defined as the percentage of patients achieving best response of CR.

    Measured: Up to 30 months

  2. Time to Response (TTR)

    TTR is defined as time from first dose of study drug to time of meeting criteria for CR or PR, whichever comes first.

    Measured: Up to 30 months

  3. Duration of Response (DOR)

    Duration of Response is defined as time from achieving either CR or PR, whichever comes first, to time of progression or starting another LGLL treatment, whichever comes first.

    Measured: Up to 30 months

  4. Duration of Complete Response

    Duration of CR is defined as time from achieving CR to time of progression or starting another LGLL treatment, whichever comes first.

    Measured: Up to 30 months

  5. Time to Complete Response

    Time to CR is defined as time from first dose of study drug to time of CR

    Measured: Up to 30 months

  6. Duration of Complete Response with Normalization of PB LGL Count

    Rate of CR with normalization of PB LGL count is defined as meeting criteria for CR AND a normal PB LGL count ( <400/mm³ CD3+CD57+ cells or <650/mm³ CD8+ T cells in PB).

    Measured: Up to 30 months

  7. Progression Free Survival

    PFS is defined as time from first dose of study drug to time of disease progression or starting another LGLL treatment, whichever comes first

    Measured: Up to 30 months

Timeline

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

  1. First posted7 Apr 2022
  2. Study start15 Feb 2023
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

Why it stopped: lack of efficacy/futility

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316116
Sponsor's protocol ID
MCC-21035
Status last verified
Feb 2026
First submitted
30 Mar 2022
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Siltuximab in people with Large Granular Lymphocyte Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 20 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Feb 2026. 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 stopped early (reason given: lack of efficacy/futility). Results are not available in the source record.

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?

Overall Response Rate (time frame: Up to 30 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 NCT05316116.

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 5 Feb 2026.

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