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Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05316116
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
EUSA Pharma, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief 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).

Condition or disease Intervention/treatment Phase
Large Granular Lymphocyte Leukemia Drug: Siltuximab Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)
Actual Study Start Date : March 29, 2022
Estimated Primary Completion Date : September 20, 2024
Estimated Study Completion Date : September 2025


Arm Intervention/treatment
Experimental: Siltuximab
Siltuximab will be given every 3 weeks, for between 18 and 36 weeks
Drug: Siltuximab
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).
Other Name: Interleukin-6




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 30 months ]
    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


Secondary Outcome Measures :
  1. Complete Response Rate (CR) [ Time Frame: Up to 30 months ]
    CR rate is defined as the percentage of patients achieving best response of CR.

  2. Time to Response (TTR) [ Time Frame: Up to 30 months ]
    TTR is defined as time from first dose of study drug to time of meeting criteria for CR or PR, whichever comes first.

  3. Duration of Response (DOR) [ Time Frame: Up to 30 months ]
    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.

  4. Duration of Complete Response [ Time Frame: Up to 30 months ]
    Duration of CR is defined as time from achieving CR to time of progression or starting another LGLL treatment, whichever comes first.

  5. Time to Complete Response [ Time Frame: Up to 30 months ]
    Time to CR is defined as time from first dose of study drug to time of CR

  6. Duration of Complete Response with Normalization of PB LGL Count [ Time Frame: Up to 30 months ]
    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).

  7. Progression Free Survival [ Time Frame: Up to 30 months ]
    PFS is defined as time from first dose of study drug to time of disease progression or starting another LGLL treatment, whichever comes first



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 which includes both of the following:
  • a. Peripheral blood with CD3+ CD57+ cells >400/mm³ or CD8+ cells >650/mm³, AND b. evidence for clonal T cell receptor gene rearrangement by PCR.
  • Has at least one of the indications for treatment:

    1. severe neutropenia less than 500/mm³, OR
    2. neutropenia associated with recurrent infection, OR
    3. symptomatic anemia with Hemoglobin < 9 g/dL, OR
    4. transfusion-dependent anemia with transfusion needs >= 1 u per month, OR
    5. severe thrombocytopenia <20,000/mm³, OR
    6. 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.

Exclusion Criteria:

  • 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.
  • 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.

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): NCT05316116


Contacts
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Contact: Richard Corona 813-745-3465 Richard.Corona@moffitt.org
Contact: Lubomir Sokol, MD, PhD 813-745-3069 Lubomir.Sokol@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Richard Corona    813-745-3465    Richard.Corona@moffitt.org   
Principal Investigator: Lubomir Sokol, MD, PhD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
EUSA Pharma, Inc.
Investigators
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Principal Investigator: Lubomir Sokol, MD, PhD Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT05316116    
Other Study ID Numbers: MCC-21035
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell
Siltuximab
Antineoplastic Agents