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

Part of paid clinical trials in Huntington Park, California.

Sponsor
Grifols Therapeutics LLC
Study ID
NCT05645107
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Chronic Lymphocytic Leukemia
  • Bacterial Infections
  • Hypogammaglobulinemia
  • Multiple Myleoma
  • Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xembify — DRUG
    SC infusion pump
  • Placebo — DRUG
    SC infusion pump

Study Details

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.

Key Dates

Start date
Dec 26, 2022
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XEMBIFY + Standard Medical Treatment (SMT)
    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.
  • Placebo Comparator: Placebo + SMT
    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.

Primary Outcome Measure

Annual Rate of Major Bacterial Infections per Year [ Time Frame: Up to Week 51 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
GC2202 Study Site 115Huntington ParkCalifornia90255
GC2202 Study Site 103St. PetersburgFlorida33701
GC2202 Study Site 111BethesdaMaryland20889
GC2202 Study Site 109GreenvilleNorth Carolina27843
GC2202 Decentralized Study Site 114MorrisvilleNorth Carolina27560
GC2202 Study Site 105CantonOhio44718
GC2202 Study Site 110RockvilleSouth Carolina29732-

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