Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05316116




Registration number
NCT05316116
Ethics application status
Date submitted
30/03/2022
Date registered
7/04/2022

Titles & IDs
Public title
Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)
Scientific title
A Pilot Study of Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)
Secondary ID [1] 0 0
MCC-21035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Large Granular Lymphocyte Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Siltuximab

Experimental: Siltuximab - Siltuximab will be given every 3 weeks, for between 18 and 36 weeks


Treatment: Drugs: 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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Complete Response Rate (CR)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [2] 0 0
Time to Response (TTR)
Timepoint [2] 0 0
Up to 30 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Duration of Complete Response
Timepoint [4] 0 0
Up to 30 months
Secondary outcome [5] 0 0
Time to Complete Response
Timepoint [5] 0 0
Up to 30 months
Secondary outcome [6] 0 0
Duration of Complete Response with Normalization of PB LGL Count
Timepoint [6] 0 0
Up to 30 months
Secondary outcome [7] 0 0
Progression Free Survival
Timepoint [7] 0 0
Up to 30 months

Eligibility
Key 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 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
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
EUSA Pharma, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ning Dong, MD, MS
Address 0 0
Moffitt Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Richard Corona
Address 0 0
Country 0 0
Phone 0 0
813-745-3465
Fax 0 0
Email 0 0
Richard.Corona@moffitt.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05316116