Chronic Lymphocytic Leukemia Clinical Trial

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia

Summary

The primary purpose of the study is to evaluate whether weekly 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 participants with hypogammaglobulinemia (HGG) associated with B-cell leukemia-cll/" >chronic lymphocytic leukemia (CLL) in comparison to the Placebo plus SMT group.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants ≥18 years of age at screening
Participants with documented and confirmed diagnosis of B-cell CLL according to International Workshop on CLL (iwCLL) criteria.
Participants with hypogammaglobulinemia with immunoglobulin G (IgG) levels <4 grams per liter (g/L)
Participants with RAI staging of intermediate (1 and 2) or high (3 and 4) as documented in the participant's medical history.
Participants with documented history of at least one severe bacterial infection or recurrent bacterial infections (that is., ≥ 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).

Exclusion Criteria:

Participants with documented history of hematopoietic stem cell transplant.
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 or receiving therapeutic or prophylactic antibiotic treatment at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines or recommended in the updated labelling of specific antileukemic medicines used during the participation in the trial is 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 are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [example, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [example, fondaparinux]).
Participants currently have a known hyperviscosity syndrome or hypercoagulable states.
Participants have a known previous infection with 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] more than (>)140 millimeters of mercury (mmHg) and/or diastolic blood pressure [DBP] >90 mmHg), and/or a heart rate (HR) >100 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).

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

386

Study ID:

NCT05645107

Recruitment Status:

Recruiting

Sponsor:

Grifols Therapeutics LLC

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There are 25 Locations for this study

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JD Medical Group LLC
Miami Florida, 33176, United States More Info
Felipe Gascon-Radon, Dr
Contact
786-420-2392
[email protected]
Silvia Hernandez
Contact
+1 614-505-1946
[email protected]
Gabrail Cancer and Research Center
Canton Ohio, 44718, United States More Info
Nashat Gabrail
Contact
[email protected]
Amanda Rich
Contact
[email protected]
Optimed Research, LLC
Columbus Ohio, 43235, United States More Info
Donald McNeil, Dr.
Contact
[email protected]
Sana Yousif
Contact
[email protected]
Allergy and Clinical Immunology Associates
Pittsburgh Pennsylvania, 15241, United States More Info
Michael Palumbo, Dr.
Contact
[email protected]
Carolina Blood and Cancer Care
Rockville South Carolina, 29732, United States More Info
Viral Rabara
Contact
[email protected]
Sandra Nixon
Contact
[email protected]
Valley Cancer Associates
Harlingen Texas, 78550, United States More Info
Todd Shenkenberg
Contact
[email protected]
Elyssa Navarro
Contact
[email protected]
"University multiprofile hospital for active treatment - Burgas" AD, Internal diseases II level, clinical hematology I level
Burgas , 8000, Bulgaria More Info
Dimitar Ribov
Contact
[email protected]
Yanitsa Dimitrova
Contact
[email protected]
"Medical Center Leo Clinic" EOOD, consulting room 15
Plovdiv , 4003, Bulgaria More Info
Boyan Semov
Contact
[email protected]
Anna Filipova
Contact
[email protected]
"Complex oncology center - Ruse" EOOD, Department - medical oncology II level
Ruse , 7000, Bulgaria More Info
Galina Hvarchilkova
Contact
[email protected]
"University First multiprofile hospital for active treatment - Sofia "St. Joan Krastitel"" EAD, Third Department of Internal Diseases
Sofia , 1142, Bulgaria More Info
Tanya Russeva
Contact
[email protected]
Ralitsa Ljubenova
Contact
[email protected]
"University multiprofile hospital for active treatment "Sv. Ivan Rilski"" EAD, Department of clinical hematology at Clinical Hematology Clinic - clinical hematology III level
Sofia , 1431, Bulgaria More Info
Atanas Radinoff
Contact
[email protected]
Julian Radinoff
Contact
[email protected]
"University multiprofile hospital for active treatment and emergency medicine "N.I. Pirogov"" EAD, Internal diseases - internal diseases III level
Sofia , 1606, Bulgaria More Info
Petar Atanasov
Contact
[email protected]
Iglika Mladenova
Contact
[email protected]
"Medical Center "Sirtuin"" Ltd, consulting room 7
Sofia , 1612, Bulgaria More Info
Maria Anastasova-Postadzhiyan
Contact
[email protected]
Hristo Pavlov
Contact
[email protected]
"""Specialized Hospital for active treatment of hematological diseases"" EAD, First department clinical hematology to clinic on clinical hematology - clinical hematology III level"
Sofia , 1797, Bulgaria More Info
Tanya Yankova
Contact
[email protected]
Nansi Veleva
Contact
[email protected]
"Specialized Hospital for active treatment of hematological diseases" EAD, Second department clinical hematology to clinic on clinical hematology - clinical hematology III level
Sofia , 1797, Bulgaria More Info
Milan Jagurinoski
Contact
[email protected]
Hristo Pavlov
Contact
[email protected]
Wojewodzki Szpital Specjalistyczny w Legnicy, Oddzial Hematologii
Legnica Dolnośląskie, 59-22, Poland More Info
Jadwiga Holojda
Contact
[email protected]
Barbara Boruta-Pankowska
Contact
[email protected]
Centrum Medyczne MICS Torun
Toruń Kujawsko-pomorskie, 87-10, Poland More Info
Dominik Chraniuk
Contact
[email protected]
Ewa Rymko
Contact
[email protected]
Wojewodzki Szpital Specjalistyczny imienia Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Hematologii
Słupsk Pomorskie, 76-20, Poland More Info
Wojciech Homenda
Contact
[email protected]
Magdalena Pierzchalska
Contact
[email protected]
Onco Card Srl
Brasov RO, 50005, Romania More Info
Mihaela Lazaroiu
Contact
[email protected]
Spitalul Clinic Coltea
Bucuresti RO, 30171, Romania More Info
Gabriela Borsaru
Contact
[email protected]
Cristina Serban
Contact
[email protected]
IOCN
Cluj-Napoca RO, 40001, Romania More Info
Ciprian Tomuleasa
Contact
[email protected]
Anamaria Bancos
Contact
[email protected]
Spitalul Clinic Municipal de Urgenta Timisoara
Timisoara RO, 30004, Romania More Info
Ioana Ionita
Contact
[email protected]
Mona Bardan
Contact
[email protected]
"University Clinical Center of Serbia, Clinic of Hematology"
Belgrade , 11000, Serbia More Info
Darko Antic
Contact
[email protected]
"University Clinical Center Kragujevac, Clinic of Hematology"
Kragujevac , 34000, Serbia More Info
Danijela Jovanovic
Contact
[email protected]
"University Clinical Center Nis, Clinic for Hematology, Alergology and Clinical Immunology "
Nis , 18000, Serbia More Info
Vesna Nikolic
Contact
[email protected]
"Oncology Institute of Vojvodina, Clinic for Internal Oncology "
Sremska Kamenica , 21204, Serbia More Info
Dragana Petrovic
Contact
[email protected]
Dijana Zekić
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

386

Study ID:

NCT05645107

Recruitment Status:

Recruiting

Sponsor:


Grifols Therapeutics LLC

How clear is this clinincal trial information?

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