Study on Human Normal Immunoglobulin and Sodium Chloride to Prevent Infections in Patients with Chronic Lymphocytic Leukemia

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What is this study about?

This clinical trial is focused on patients with certain types of blood cancers, specifically B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma. These conditions can lead to a weakened immune system, making patients more prone to infections. The study is testing a treatment called Xembify, which is a form of Human Normal Immunoglobulin. This is a substance derived from blood that helps boost the immune system. The trial will compare the effects of Xembify combined with standard medical treatment to a placebo combined with standard medical treatment. The goal is to see if Xembify can help reduce the number of serious infections in these patients.

Participants in the study will receive weekly injections of either Xembify or a placebo for a period of one year. The injections are given under the skin, a method known as subcutaneous injection. Throughout the study, researchers will monitor the participants to track the number of major bacterial infections they experience. The study aims to determine if Xembify can lower the rate of these infections compared to the placebo.

The trial will also look at other factors, such as how long it takes for the first major infection to occur, the total number of infections, and the number of days participants need antibiotics. Additionally, the study will record any hospitalizations due to infections. By gathering this information, researchers hope to better understand the potential benefits of Xembify for patients with these blood cancers and weakened immune systems.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

You must meet specific criteria, including being 18 years or older, having a confirmed diagnosis of B-cell chronic lymphocytic leukemia, and having low levels of immunoglobulin G (IgG).

2 initial assessment

An initial assessment will be conducted to evaluate your health status. This may include a review of your medical history and a physical examination.

Your eligibility will be confirmed based on your medical history, including any previous severe or recurrent bacterial infections.

3 treatment phase

During the treatment phase, you will receive either **Xembify** or a placebo, in addition to standard medical treatment. **Xembify** is a solution for injection administered under the skin (subcutaneous).

The treatment will be administered weekly over a one-year period. The goal is to reduce the rate of major bacterial infections.

4 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment.

You will be asked to report any infections or side effects you experience. This information is crucial for evaluating the treatment’s impact.

5 completion of the study

At the end of the one-year treatment period, a final assessment will be conducted to evaluate your overall health and the outcomes of the study.

The results will contribute to understanding the effectiveness of **Xembify** in preventing infections in patients with conditions like yours.

Who Can Join the Study?

  • Participants must be 18 years of age or older.
  • Participants must have a confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL). This is a type of cancer that affects certain white blood cells.
  • Participants must have low levels of immunoglobulin G (IgG), which is a type of antibody, with levels less than 4 grams per liter (g/L).
  • Participants must have a RAI stage of intermediate (1 and 2) or high (3 and 4). RAI staging is a way to describe the extent of CLL.
  • Participants must have a history of at least one severe bacterial infection or at least three recurrent bacterial infections in the past year. Severe infections are those that are classified as Grade 3 or higher according to a standard scale used to measure the severity of side effects.
  • Participants must have signed an informed consent form, which means they agree to participate in the study after being informed about all aspects of the trial.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than chronic lymphocytic leukemia (a type of blood cancer).
  • Patients who have had a major bacterial infection in the past month.
  • Patients who are currently receiving treatment that might interfere with the study.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial in the last 30 days.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Spitalul Clinic Municipal De Urgenta Timisoara Timisoara Romania
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Wojewodzki Szpital Specjalistyczny W Legnicy Legnica Poland
University Hospital Sveti Duh Zagreb Croatia
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Multiprofessional Hospital For Active Treatment Health 2012 OOD Sofia Bulgaria
Onco Card S.R.L. Brasov Romania
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Orszagos Onkologiai Intezet Budapest Hungary
University Of Debrecen Debrecen Hungary
Spitalul Clinic Coltea Bucharest Romania
Spitalul Clinic Colentina Bucuresti Bucharest Romania
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Institutul Regional De Oncologie Iasi Iasi Romania
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
In Vivo Sp. z o.o. Bydgoszcz Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Complex Oncology Center Ruse EOOD Ruse Bulgaria
University Of Szeged Szeged Hungary
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Nasz Lekarz Przychodnie Medyczne Sp. z o.o. Torun Poland
Fundeni Clinical Institute Bucharest Romania
Gkdtuxngatonjemrt Vphubefzz Pyvh Aryqoa Erdcccfg Oatgfg Kcybjn Gyor Hungary
Saizwbqqzgsymqb Sefidlf Mwlhiqo Iiztsfkeahk Kmswakdat Torun Poland
Mteczgd Cyhywb Phonqtpxjqo Lawv Sofia Bulgaria
Mpnhyoomgr Cbhlje Sqfhvbn Lcnj Sofia Bulgaria
Kekzzqja bwarmgei cxnnvx Rivcic (mxbdwyjc Hljtmnde Cmpjox Rexkwnn Rijeka Croatia
Muxrvnl Cusosv Pmuqog Cmkmsu Emxf Lovech Bulgaria
Muoaerf Ciypct Modcqvsgqb &gsjczp Bltcss Burgas Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
31.08.2023
Croatia Croatia
Recruiting
31.08.2023
Hungary Hungary
Recruiting
31.08.2023
Poland Poland
Recruiting
31.08.2023
Romania Romania
Recruiting
31.08.2023

Trial locations

XEMBIFY is a medication used in this clinical trial to help prevent infections in patients with certain types of blood cancers, such as B-cell chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. It is given to patients who have low levels of antibodies, which are proteins in the blood that help fight infections. XEMBIFY is a type of immunoglobulin therapy, which means it provides extra antibodies to help the body fight off infections more effectively. In this trial, XEMBIFY is used alongside standard medical treatments to see if it can reduce the number of serious bacterial infections in these patients over a year.

Investigated diseases:

Chronic lymphocytic leukemia – Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell, in the blood. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. As the disease advances, it may cause anemia, bleeding problems, and an increased risk of infections due to the immune system’s impaired function. The progression of chronic lymphocytic leukemia can vary greatly among individuals, with some experiencing a slow course and others a more rapid progression.

Trial ID:
2022-502193-16-00
Protocol code:
GC2202
NCT ID:
NCT05645107
Trial Phase:
Therapeutic confirmatory (Phase III)

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