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A Pediatric Phase I Pharmacokinetic Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease

Phase 1
18 Years
Not Enrolling
Graft vs Host Disease

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Trial Information

A Pediatric Phase I Pharmacokinetic Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease

Inclusion Criteria:

- Patients must have received corticosteroids at >= 2 mg/kg/day for a minimum of 72
hours prior to study entry.

- Overall clinical grade II-IV acute GVHD (aGVHD) with intestinal involvement with
biopsy of at least one site "consistent with" aGVHD. Acute GVHD is defined in this
study as occurring within 100 days after transplant.

- Men and women of childbearing potential must use adequate birth control measures
(e.g., abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, or surgical sterilization) for the duration of the study and should
continue such precautions for 6 months after receiving the study drug infusion.

- Parent(s)/legal guardian must give informed consent

Exclusion Criteria:

- Patients with uncontrolled infection(s), i.e. documented bacterial, viral or fungal
infection within 72 hours prior to study entry. Neither continuation of antibiotics
for a controlled infection nor prophylactic/empiric antibiotics warrant exclusion.

- Patients with any one of the following opportunistic infections documented within 8
weeks prior to study entry are excluded: cytomegalovirus disease, pneumocystis
carinii, aspergillosis, histoplasmosis, atypical mycobacterium infection or other
pathogenic molds/fungi.

- Serum creatinine > 1.5 mg/dl at study entry.

- Women who are pregnant, nursing, or planning pregnancy within 6 months following
study drug infusion.

- Use of any investigational drug for the treatment of acute GVHD within 14 days prior
to study entry. An investigational drug is defined as one that is being given on
study, requiring informed consent.

- Use of ATG or similar product within 14 days prior to study entry requires study
chair approval. Judgment will be based on ATG dosing and timing.

- Previous administration of infliximab.

- Any allergy to murine products.

- Documented HIV infection.

- Patients with grade IV renal, hepatic, pulmonary, or neurologic toxicity by National
Cancer Institute (NCI) Common Toxicity Criteria (CTC).

- Patients with any history of congestive heart failure, defined as cardiac dysfunction
requiring inotropic support other than dopamine at <= 5 mcg/kg/minute.

- Peripheral neuropathy or any demyelinating disease, greater than CTC grade 1.

- Presence of a transplanted solid organ (with the exception of a corneal transplant >
3 months prior to screening).

- Any prior history of tuberculosis (TB). Patients with a recent close contact with an
individual with active TB are excluded. Patients with a household member who has a
history of pulmonary TB should have a thorough evaluation for TB prior to study
enrolment as recommended by a local infectious disease specialist or by guidelines on
TB screening published by the United States (US) Federal Centers for Disease Control
and Prevention (CDC).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Barbara Sleight, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

October 2006

Related Keywords:

  • Graft Vs Host Disease
  • Recipients of an allogeneic hematopoietic stem cell transplant who have acute GVHD
  • Graft vs Host Disease
  • Necrosis



Children's Healthcare of Atlanta/Emory UniversityAtlanta, Georgia  30322