Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care, Treatment Closed any age GUMC-12089 NCI-V89-0237

Objectives

I.  Evaluate the efficacy of continuous vs. weekly infusion of intravenous 
immunoglobulin (IVIG) in the prevention of infections following marrow 
transplantation.
II.  Evaluate the toxicities of continuous infusional IVIG.
III.  Perform pharmacokinetic analysis of anti-CMV IgG.
IV.  Study the effect of titration of IVIG dose to achieve an IgG level of at 
least 1,200 mg/dl (minimal levels seen in patients who do not develop GVHD) on 
the incidence of acute GVHD following allogeneic bone marrow transplantation.
V.  Study reconstitution of both the cellular and humoral immune system 
following transplantation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

All patients undergoing allogeneic or 
autologous marrow grafts regardless of age.  Patients with a history of 
anaphylaxis or severe systemic response to immune globulin or serum therapy 
are excluded, as are those with serum IgA deficiencies who have anti-IgA 
antibodies.

Expected Enrollment

In a pilot study, the first 20 allogeneic transplant patients whose IgG levels 
fall below 1,200 mg/dl will be randomized to treated and untreated groups.  It 
is expected that 10 treated patients will be sufficient to assess the 
incidence of GVHD.  After GVHD rates are estimated in the treated and 
untreated groups, up to 50 additional patients will be accrued so that valid 
statistical comparisons can be made between the two groups.

Outline

Nonrandomized study.
Infection Prophylaxis for Transplant Patients.  Intravenous Immune globulin, 
Gamimune-N, IVIG.

Trial Contact Information

Trial Lead Organizations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Thomas Spitzer, MD, Protocol chair		Ph: 617-724-1124; 877-726-5130