myelodysplastic syndrome (MDS) MedDRA version: 7.1 Level: LLT Classification code 10028533
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentrat
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Confirmed diagnosis (within one month prior to randomization) of myelodysplasia ? Bone marrow (BM) blasts = 10 % (corresponding to RA, RARS, RAEB with = 10 %BM blasts in the FAB classification). ? Hemoglobin < 10 g/dl or 6.2 mmol/l, or RBC transfusion dependent, and/or neutrophil count < 1.5 x 109 /l and/or platelet count < 100 x 109/l or platelet transfusion dependent. ? No poor cytogenetics (complex abnormalities or involvement of chromosome 7) . (Patients with unknown cytogenetics could also be included provided reasonable efforts have been made for determining the cytogenetic profile and the results are considered as a failure – ex: NN with = 10 metaphases). ? At least 6 weeks prior to randomization without treatment for MDS (including hematopoietic growth factors) other than supportive care only ? At least 3 months without treatment with any other therapeutic agent targeted at reducing TNF (i.e., pentoxifylline, thalidomide, etanercept etc.) prior to randomization ? Age = 18 years ? WHO performance status 0, 1 or 2 (Appendix B) ? Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion. ? Pregnant or nursing women are not eligible. Women of childbearing potential must have a negative serum pregnancy test performed within 1 week before randomization ? The patient must be screened for tuberculosis (TB) prior to enrollment. According to the screening patients are considered eligible if the following criteria apply (in chronological order of evaluations to be performed): ? No current or prior active or latent tuberculosis (TB) irrespective of receiving or having received adequate treatment and no recent close contact with an individual with active TB ? A chest X-Ray within 6 weeks prior to randomization shows no evidence of prior or current active TB infection such as fibrotic or pleural scaring, pulmonary nodules, mediastinal and /or hilar lymphadenopathy, upper lobe volume loss, cavitation. ? Negative intradermal tuberculin skin test within 6 weeks prior to randomisation. The performance and interpretation of the test must be done in accordance with the guidelines specified in section 3.1 of the protocol ? Absence of current or prior history of an opportunistic infection (eg. Herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening ? Absence of other severe (CTCAE grade III-IV) active , chronic or recurrent infections, documented HIV, documented current active hepatitis B or history of a documented hepatitis C ? No severe cardiac dysfunction (NYHA criteria grade III or IV; see Appendix C) or evidence of congestive heart failure (CHF), or left-ventricular ejection fraction (LVEF) = 35%, or clinical history of CHF ? No severe pulmonary dysfunction ? Serum bilirubin = 1.5 X UNL (Upper Normal Limit) and ALAT and ASAT levels = 2.5 X UNL for the institution laboratory ? Serum creatinine levels = 1.5 X UNL for the institution laboratory ? No poor medical risk because of other systemic disease ? No recent history of allergies ? No previous administration of infliximab or other monoclonal antibodies ? No history of clinically significant AEs to murine or chimeric proteins or hum
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in MDS patients with = 10% bone marrow (BM) blasts (RA, RARS, RAEB with = 10% BM blasts) the therapeutic activity of two different dosages of infliximab on peripheral blood cell count as well as peripheral and bone marrow (BM) blast cell coun;Secondary Objective: To further characterize the subjective and objective toxicity of infliximab in low or intermediate risk MDS patients.;Primary end point(s): Response rate (CR, PR and HI) | — |
Countries
Czech Republic
Outcome results
None listed