NCT00074074

Infliximab in Treating Patients With Myelodysplastic Syndrome

Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as infliximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to study the effectiveness of infliximab in treating patients who have myelodysplastic syndrome.

Detailed description

OBJECTIVES: * Determine the therapeutic activity of 2 different doses of infliximab on peripheral blood cell count and peripheral and bone marrow blast cell count in patients with low- or intermediate-risk myelodysplastic syndromes. * Determine the subjective and objective toxicity of these regimens in these patients. * Determine the response rates (complete and partial response and hematological improvement) in patients treated with these regimens. * Determine the duration of response in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetics (good vs intermediate vs unknown due to failure), overall International Prognostic Scoring System score (low \[0\] vs intermediate 1 \[0.5-1.0\] vs intermediate 2 \[1.5-2.0\]), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive infliximab IV on days 1, 15, 43, 71, 99, 127, 155, and 183 in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive a higher dose of infliximab as in arm I. Patients achieving response (complete or partial response or hematological improvement) continue therapy beyond day 183 in the absence of disease progression. Patients are followed at 2 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 2 years.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	infliximab

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-12-01
• First posted: 2003-12-11
• Last updated: 2012-07-16

Locations

19 sites across 6 countries: Belgium, Czechia, France, Germany, Italy, Netherlands