2022-502193-16-00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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 42
- 主要终点
- Annual rate of major infections* (bacterial; infections per year). *Major bacterial infections for the primary endpoint are defined in the appendix “Diagnostic Criteria for Serious Infection Types” from the FDA IVIG PID guidance 2008, which includes bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess
研究概览
简要总结
To evaluate whether weekly administered XEMBIFY + Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per subject per year in subjects with HGG associated with B-cell CLL in comparison to the Placebo + SMT group.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects ≥18 years of age at Screening Visit
- •Subjects with documented and confirmed diagnosis of B-cell CLL according to International Workshop on CLL (iwCLL) criteria
- •Subjects with hypogammaglobulinemia with IgG levels <4 g/L
- •Subjects with RAI staging of intermediate (1 and 2) or high (3 and 4) as documented in the subject’s medical history
- •Subjects with documented history of at least one severe bacterial infection or recurrent bacterial infections (i.e. ≥ 3 infections) within 12 months before the Screening Visit. Severe bacterial infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events [CTCAE] Grades)
- •Subjects have signed an informed consent form (ICF) prior to initiation of any study procedures
排除标准
- •Subjects with documented history of hematopoietic stem cell transplant
- •Subjects 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 subject. (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.)
- •Subjects with severe known kidney disease (as defined by estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) as determined by the Principal Investigator
- •Subjects 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
- •Subjects who 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 (e.g., myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis
- •Subjects who are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [e.g., fondaparinux])
- •Subjects who currently have a known hyperviscosity syndrome or hypercoagulable states
- •Subjects who have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection
- •Subjects with non-controlled arterial hypertension (systolic blood pressure [SBP] >140 mmHg and/or diastolic blood pressure [DBP] >90 mmHg), and a heart rate (HR) >100 bpm
- •Subjects have known substance or prescription drug abuse within 12 months before the Screening Visit
- •Subjects 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
- •Subjects have participated in another clinical trial within 30 days prior to Screening Visit (observational studies without investigative treatments [non-interventional] are permitted)
- •Subjects/caregivers are unwilling to comply with any aspect of the protocol for the duration of the study
- •In the opinion of the investigator, subjects may have compliance problems with the protocol and the procedures of the protocol
- •Subjects with active infections or receiving therapeutic or prophylactic antibiotic treatment at time of Screening Visit. Specific supportive anti-infective prophylactics defined in the CLL NCCN or iwCLL guidelines or recommended in the updated labelling of specific antileukemic medicines used during the participation in the trial is allowed
- •Subjects with active second malignancies
- •Subjects with known primary immunodeficiency (PI)
- •Subject with a life expectancy less than 1.5 years
- •Subjects 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
- •Subjects have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product
- •Subjects 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
结局指标
主要结局
Annual rate of major infections* (bacterial; infections per year). *Major bacterial infections for the primary endpoint are defined in the appendix “Diagnostic Criteria for Serious Infection Types” from the FDA IVIG PID guidance 2008, which includes bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess
Annual rate of major infections* (bacterial; infections per year). *Major bacterial infections for the primary endpoint are defined in the appendix “Diagnostic Criteria for Serious Infection Types” from the FDA IVIG PID guidance 2008, which includes bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess
次要结局
- Time to first onset of major bacterial infection
- Proportion of subjects who experience major bacterial infections
- Rate of all bacterial infections (serious/non-serious) as determined by the investigator
- Time to first onset of non-major bacterial infections
- Proportion of subjects who experience bacterial infections
- Number of days on antibiotics (including oral, parenteral, oral plus parenteral, prophylactic, and therapeutic) in all subjects
- Number of hospitalizations and duration due to any infections
- Number of hospitalizations and duration due to major bacterial infections
- The rate of all infections of any kind (serious/nonserious) as determined by the Investigator
- Validated infections documented by positive radiograph, fever (>38°C [>100.4°F] oral or >39°C [>102.2°F] rectal), culture, or diagnostic testing for microorganisms, e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test)
- Time to first onset of any infection
研究者
BIOPHARMA CLINICAL&PHARMACOVIGILANCE
Scientific
Grifols Therapeutics LLC
研究点 (42)
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