2026-526803-31-00招募中3 期
An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C plus Standard Medical Treatment to Prevent Infections in Participants with Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma (Sigma).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 10
- 主要终点
- SBI rate per-participant per year.
研究概览
简要总结
The primary efficacy objective is to demonstrate that the rate of serious bacterial infections (SBI) is less than 1.0 per participant per year, in participants diagnosed with B-cell Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Non-Hodgkin Lymphoma (NHL) with hypogammaglobulinemia (HGG), when treated with Gamunex-C intravenously once every 4 weeks (Q4W) + Standard Medical Treatment (SMT) over a one-year period.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or Female participants ≥18 years of age at Screening Visit.
- •Participants with documented and confirmed diagnosis of any of the diseases below: • B-cell CLL according to iwCLL criteria and Rai staging of intermediate (1 and 2) or high (3 and 4); or • MM according to the International Myeloma Working Group criteria, R-ISS stage II or, III; or • Histologically confirmed diagnosis of B-cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification.
- •Participants with HGG with IgG levels <5g/L at screening.
- •Participants must sign the informed consent form (ICF) before the initiation of any study-related procedures
排除标准
- •Participants with documented history of allogeneic hematopoietic stem cell transplant within 6 months before Screening Visit
- •Participants with severe known kidney disease (as defined by estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration [eGFR CKD-EPI] <30 mL/min/1.73 m2) as determined by the Principal Investigator
- •Participants that have liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 3 times the upper limit of normal at the Screening Visit as defined by the testing laboratory
- •Participants who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of thromboembolic events [e.g., deep vein thrombosis, pulmonary embolism, ischemic stroke (transient ischemic attack, and any ischemic cerebrovascular accident), myocardial infarction (including unstable angina and ischemic heart disease diagnosed in the last 6 months), retinal artery occlusion, mesenteric ischemia, and peripheral arterial disease (Fontaine III and IV)]*. (Fontaine I: asymptomatic. IIa: mild claudication. IIb: moderate to severe claudication. III: ischemia with rest pain. IV: ulceration or gangrene).
- •Participants who currently have a known hyperviscosity syndrome or hypercoagulable states
- •Participants who have clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection
- •Participants with non-controlled arterial hypertension (i.e., systolic blood pressure [SBP] >160 mmHg and/or diastolic blood pressure [DBP] >100 mmHg), and/or a heart rate (HR) >100 bpm
- •Participants have known substance or prescription drug abuse 12 months before the Screening Visit.
- •Participants have participated in another clinical trial within 30 days prior to Screening Visit (NOTE: observational studies without investigative treatments [non-interventional] and interventional studies to treat CLL, MM, or NHL are permitted).
- •Participants / caregivers are unwilling to comply with any aspect of the protocol for the duration of the study.
- •In the opinion of the investigator, participants may have compliance problems with the protocol and the procedures of the protocol.
- •Participants currently receiving immunoglobulin replacement therapy or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the Screening Visit
- •Participants with any active infections at the time of Screening Visit. Participants with active secondary malignancies.
- •Participants with known primary immunodeficiency disease (PID).
- •Participants with a life expectancy less than 1.5 years
- •Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk.
- •Participants who have had known serious treatment related adverse events to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product
- •Participants who have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).
- •Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study. Note: *True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
结局指标
主要结局
SBI rate per-participant per year.
SBI rate per-participant per year.
次要结局
- The rate of severe bacterial infections per participant per year
- The rate of all bacterial infections per participant per year
- Time to first onset of non-severe bacterial infection
- The proportion of participants who experience at least one bacterial infection
- Proportion of participants who experience at least one severe bacterial infection.
- Time to first onset of SBI.
- Time to first onset of severe bacterial infection.
- The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year
- Time to first onset of any kind of infection (bacterial/viral/fungal).
- The proportion of participants who experience a validated infection.
- The rate of validated (as defined above) infections per participant per year
- Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral).
- The number of days on prophylactic antibiotics per participant per year
- Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral).
- The number of days on therapeutic antibiotics per participant per year
- Number of hospitalizations and total duration of hospitalizations due to any infections.
- The rate of hospitalizations per participant per year due to any infections
- Rate of infections requiring IV administration of an antibiotic or antiviral/anti-infective per-participant per year.
研究者
Scientific Innovation Office
Scientific
Grifols Therapeutics LLC
研究点 (10)
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