RecruitingPhase III🇵🇱 PolandEN originalLymphomaLeukemia

A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Osoby w wieku 18 lat i starsze.
  • Osoby z potwierdzoną diagnozą białaczki limfocytowej B, szpiczaka mnogiego lub chłoniaka nieziarniczego B.
  • Osoby z niskim poziomem przeciwciał (IgG poniżej 5 g/L).
  • Osoby, które w ciągu ostatniego roku miały co najmniej jedną ciężką infekcję bakteryjną lub wirusową, albo co najmniej 3 nawracające infekcje bakteryjne lub wirusowe.

✗ Disqualifies

  • Osoby po przeszczepie komórek macierzystych w ciągu ostatnich 24 miesięcy (przeszczep od dawcy) lub 3 miesięcy (przeszczep własnych komórek).
  • Osoby, które w ciągu ostatnich 6 miesięcy przyjmowały lub przyjmują leczenie immunoglobulinami (terapia zastępcza przeciwciał).
  • Osoby z aktywną infekcją w czasie wizyty kwalifikacyjnej.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (62)

GC2202 Study Site 115

Huntington Park, United States

GC2202 Study Site 103

St. Petersburg, United States

GC2202 Study Site 111

Bethesda, United States

GC2202 Study Site 109

Greenville, United States

GC2202 Decentralized Study Site 114

Morrisville, United States

GC2202 Study Site 105

Canton, United States

GC2202 Study Site 110

Rockville, United States

GC2202 Study Site 702

Banja Luka, Bosnia and Herzegovina

GC2202 Study Site 703

Mostar, Bosnia and Herzegovina

GC2202 Study Site 701

Sarajevo, Bosnia and Herzegovina

GC2202 Study Site 202

Burgas, Bulgaria

GC2202 Study Site 203

Plovdiv, Bulgaria

GC2202 Study Site 210

Plovdiv, Bulgaria

GC2202 Study Site 205

Rousse, Bulgaria

GC2202 Study Site 209

Sofia, Bulgaria

GC2202 Study Site 201

Sofia, Bulgaria

GC2202 Study Site 206

Sofia, Bulgaria

GC2202 Study Site 207

Sofia, Bulgaria

GC2202 Study Site 211

Sofia, Bulgaria

GC2202 Study Site 212

Sofia, Bulgaria

GC2202 Study Site 213

Sofia, Bulgaria

GC2202 Study Site 204

Sofia, Bulgaria

GC2202 Study Site 208

Sofia, Bulgaria

GC2202 Study Site 214

Stara Zagora, Bulgaria

GC2202 Study Site 801

Rijeka, Croatia

GC2202 Study Site 802

Zagreb, Croatia

GC2202 Study Site 305

Székesfehérvár, Hungary

GC2202 Study Site 301

Budapest, Hungary

GC2202 Study Site 308

Budapest, Hungary

GC2202 Study Site 306

Debrecen, Hungary

GC2202 Study Site 304

Eger, Hungary

GC2202 Study Site 302

Győr, Hungary

GC2202 Study Site 307

Szeged, Hungary

GC2202 Study Site 303

Szekszárd, Hungary

GC2202 Study Site 402

Torun, Poland

GC2202 Study Site 401

Krakow, Poland

GC2202 Study Site 401

Krakow, Poland

GC2202 Study Site 403

Legnica, Poland

GC2202 Study Site 406

Wałbrzych, Poland

GC2202 Study Site 406

Wałbrzych, Poland

GC2202 Study Site 405

Słupsk, Poland

GC2202 Study Site 408

Bydgoszcz, Poland

GC2202 Study Site 410

Krakow, Poland

GC2202 Study Site 409

Olsztyn, Poland

GC2202 Study Site 407

Torun, Poland

GC2202 Study Site 511

Bucharest, Romania

GC2202 Study Site 501

Bucharest, Romania

GC2202 Study Site 503

Brasov, Romania

GC2202 Study Site 504

Bucharest, Romania

GC2202 Study Site 506

Cluj-Napoca, Romania

GC2202 Study Site 502

Timișoara, Romania

GC2202 Study Site 509

Bucharest, Romania

GC2202 Study Site 508

Bucharest, Romania

GC2202 Study Site 507

Constanța, Romania

GC2202 Study Site 510

Iași, Romania

GC2202 Study Site 602

Belgrade, Serbia

GC2202 Study Site 604

Belgrade, Serbia

GC2202 Study Site 605

Belgrade, Serbia

GC2202 Study Site 607

Belgrade, Serbia

GC2202 Study Site 603

Kamenitz, Serbia

GC2202 Study Site 601

Kragujevac, Serbia

GC2202 Study Site 606

Niš, Serbia

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.

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