Completed

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

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What is being tested

Data Collection

Who is being recruted

Bone Marrow Diseases
+6

+ Disease
+ Hematologic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia 
NCT00074074
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
46 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bone Marrow Diseases
Disease
Hematologic Diseases
Myelodysplastic Syndromes
Neoplasms
Pathologic Processes
Precancerous Conditions
Preleukemia
Syndrome
Criteria

DISEASE CHARACTERISTICS: * Confirmed diagnosis (within the past month) of low- or intermediate-risk myelodysplastic syndromes (MDS) meeting all of the following criteria: * No more than 10% bone marrow blasts (corresponding to refractory anemia \[RA\], RA with ringed sideroblasts, or RA with excess blasts) * Meets at least 1 of the following hematopoietic criteria: * Hemoglobin no greater than 10 g/dL OR red blood cell transfusion dependent * Neutrophil count no greater than 1,500/mm\^3 * Platelet count no greater than 100,000/mm\^3 OR platelet transfusion dependent * No poor cytogenetics (complex abnormalities or involvement of chromosome 7) * Patients with unknown cytogenetics may be eligible provided reasonable efforts have been made for determining the cytogenetic profile and the results are considered a failure (e.g., normal karyotype \[NN\] with no more than 10 metaphases) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * No history of documented hepatitis C * No documented active hepatitis B * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT less than 2.5 times ULN Renal * Creatinine less than 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease * No clinical history or evidence of congestive heart failure * No severe cardiac dysfunction * LVEF greater than 35% Pulmonary * No prior or concurrent active or latent tuberculosis (TB) * No evidence of prior or concurrent active TB (i.e., fibrotic or pleural scarring, pulmonary nodules, mediastinal and/or hilar lymphadenopathy, upper lobe volume loss, or cavitation) by chest x-ray * Negative intradermal tuberculin skin test (i.e., induration less than 5 mm) * No severe pulmonary dysfunction Immunologic * No prior or concurrent opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystic carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within the past 6 months * No concurrent severe (CTC grade III or IV) active, chronic, or recurrent infections * No recent history of allergies * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * No prior clinically significant adverse event to murine or chimeric proteins or human/murine recombinant products * No recent contact with an individual with active TB * No poor medical risk due to other systemic disease * No multiple sclerosis or other demyelinating disorder * No peripheral neuropathy greater than CTC grade 1 * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No prior infliximab or other monoclonal antibodies * At least 6 weeks since prior hematopoietic growth factors for MDS * At least 3 months since prior therapy targeted at reducing tumor necrosis factor (TNF) alpha (e.g., pentoxifylline, thalidomide, or etanercept) * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) * No other concurrent drugs targeted at reducing TNF alpha (e.g., pentoxifylline, thalidomide, or etanercept) Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * No prior solid organ transplantation * Corneal transplantation more than 3 months ago allowed Other * No prior randomization to this clinical trial * At least 6 weeks since prior treatment for MDS (except supportive care) * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent therapeutic-dose nonsteroidal anti-inflammatory drugs (NSAIDs) * Concurrent sporadic (no more than 3 tablets/week) over-the-counter NSAIDs allowed * Concurrent cardioprotective doses (80 mg/day or equivalent) of aspirin allowed

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 19 locations
Suspended
AZ Sint-JanBrugge, BelgiumSee the location
Suspended
Institut Jules BordetBrussels, Belgium
Suspended
Hopital Universitaire ErasmeBrussels, Belgium
Suspended
Universitair Ziekenhuis AntwerpenEdegem, Belgium
Completed19 Study Centers