NCT05645107招募中3 期
A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 386
- 试验地点
- 121
- 主要终点
- Annual Rate of Major Bacterial Infections per Year
研究概览
简要总结
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years of age at screening visit
- •Participants with documented and confirmed diagnosis of any of the below diseases:
- •B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)
- •MM according to the International Myeloma Working Group criteria (IMWG), 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 less than 5 g/L. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein [Mspike] to reflect the true polyclonal IgG concentration.)
- •Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial/viral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial/viral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades).
排除标准
- •Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.
- •Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.
- •Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and/or local/international guidelines for the CLL, and defined in local/international guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.
- •Participants with active second malignancies.
- •Participants with known primary immunodeficiency (PI).
- •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 subject at undue medical risk.
- •Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.
- •Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.
- •Participants 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).
- •Participants with severe known kidney disease [as defined by estimated glomerular filtration rate [eGFR] less than (<) 30 milliliter (mL)/min/1.73 square meter (m2)] as determined by the Principal Investigator.
- •Participants that have liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.
- •Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.
- •Participants currently have a known hyperviscosity syndrome or hypercoagulable states.
- •Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
- •Participants with non-controlled arterial hypertension (systolic blood pressure [SBP] greater than 140 millimeters of mercury (mmHg) and/or diastolic blood pressure [DBP] greater than 90 mmHg), and/or a heart rate (HR) greater than100 bpm.
- •Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.
- •Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments [non-interventional] are permitted).
研究组 & 干预措施
Placebo + SMT
Placebo Comparator
Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51.
The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
干预措施: Placebo (Drug)
XEMBIFY + Standard Medical Treatment (SMT)
Experimental
Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase).
The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation.
干预措施: Xembify (Drug)
结局指标
主要结局
Annual Rate of Major Bacterial Infections per Year
时间窗: Up to Week 51
次要结局
- Time to First Onset of Major Bacterial Infection(Up to Week 51)
- Percentage of Participants who Experience Major Bacterial Infections(Up to Week 51)
- Rate of all Bacterial Infections Determined by the Investigator(Up to Week 51)
- Percentage of Participants who Experience Bacterial Infections(Up to Week 51)
- Time to First Onset of Non-Major Bacterial Infections(Up to Week 51)
- Number of Days on Which Participants Were on Antibiotics(Up to Week 51)
- Number of Hospitalizations due to any Infections(Up to Week 51)
- Duration of Hospitalizations due to any Infections(Up to Week 51)
- Number of Hospitalizations due to Major Bacterial Infections(Up to Week 51)
- Duration of Hospitalizations due to Major Bacterial Infections(Up to Week 51)
- Rate of all Infections as Determined by the Investigator(Up to Week 51)
- Number of Participants with Validated Infections(Up to Week 51)
- Time to First Onset of any Infection(Up to Week 51)
研究者
研究点 (121)
Loading locations...
相似试验
已完成
3 期
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)Type 2 Diabetes MellitusNCT00637273AstraZeneca514
已完成
2 期
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)NASH - Nonalcoholic SteatohepatitisNCT04767529Akero Therapeutics, Inc128
已完成
2 期
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)NASH - Nonalcoholic SteatohepatitisNCT05039450Akero Therapeutics, Inc213
已完成
3 期
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.Restless Legs SyndromeNCT00298623XenoPort, Inc.222
已完成
3 期
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.Restless Legs SyndromeNCT00365352XenoPort, Inc.325