EUCTR2015-003775-30-BE进行中（未招募）1 期
A phase II pilot study to assess the presence of molecular factors predictive for hematologic response in myelodysplastic syndrome patients receiving deferasirox therapy in hematological centers in Belgium using gene expressing profiling from baseline bone marrow.
ovartis Pharma NV0 个研究点开始时间: 2015年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained prior to any other study procedure,
- •2. Males or females = 18 years of age,
- •3. MDS according to WHO criteria lasting = 14 weeks at the time of screening,
- •4. IPSS score <1.5 (low and intermediate-1 risk patients) at the time of screening using the IPSS score of 1997
- •5. Treatment with deferasirox:
- •- Only for the responder group: Treatment with deferasirox for prevention or treatment of IOL for at least 14 weeks before screening.
- •- Only for the non-responder group: Treatment with deferasirox for at least 9 months for prevention or treatment of IOL before screening to exclude patients with a late hematological response.
- •6. Only for responder-group: Patient with hematological response defined according to the IWG criteria of 2006 which must last at least 8 weeks and confirmed by the scientific advisory committee.
- •7. Only for non-responder group: confirmation by the scientific advisory committee that patient is eligible based on matched-pairing and confirmation of no hematological response. Minimal requirements for matched pairing include age, sex, IPSS score, hemoglobin level and transfusion need at baseline, treatment duration with deferasirox and time since MDS diagnosis. Pairing can be extended according to level of leukopenia, thrombocytopenia, serum ferritin level at baseline, comorbidities and transfusion history.
- •8.Bone marrow aspirate taken at the time of MDS diagnosis (at baseline) retrievable from patient’s hospital and viably frozen. This should be checked by the treating hematologist/oncologist before referring the patient for potential inclusion to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
- •1. Written informed consent obtained prior to any other study procedure,
- •2. Males or females = 18 years of age,
- •3. MDS according to WHO criteria lasting = 14 weeks at the time of screening,
- •4. IPSS score <1.5 (low and intermediate-1 risk patients) at the time of screening using the IPSS score of 1997
- •5. Treatment with deferasirox:
- •- Only for the responder group: Treatment with deferasirox for prevention or treatment of IOL for at least 14 weeks before screening.
- •- Only for the non-responder group: Treatment with deferasirox for at least 9 months for prevention or treatment of IOL before screening to exclude patients with a late hematological response.
- •6. Only for responder-group: Patient with hematological response defined according to the IWG criteria of 2006 which must last at least 8 weeks and confirmed by the scientific advisory committee.
- •7. Only for non-responder group: confirmation by the scientific advisory committee that patient is eligible based on matched-pairing and confirmation of no hematological response. Minimal requirements for matched pairing include age, sex, IPSS score, hemoglobin level and transfusion need at baseline, treatment duration with deferasirox and time since MDS diagnosis. Pairing can be extended according to level of leukopenia, thrombocytopenia, serum ferritin level at baseline, comorbidities and transfusion history.
- •8.Bone marrow aspirate taken at the time of MDS diagnosis (at baseline) retrievable from patient’s hospital and viably frozen. This should be checked by the treating hematologist/oncologist before referring the patient for potential inclusion to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
- •1. Written informed consent obtained prior to any other study procedure,
- •2. Males or females = 18 years of age,
- •3. MDS according to WHO criteria lasting = 14 weeks at the time of screening,
- •4. IPSS score <1.5 (low and intermediate-1 risk patients) at the time of screening using the IPSS score of 1997
- •5. Treatment with deferasirox:
- •- Only for the responder group: Treatment with deferasirox for prevention or treatment of IOL for at least 14 weeks before screening.
- •- Only for the non-responder group: Treatment with deferasirox for at least 9 months for prevention or treatment of IOL before screening to exclude patients with a late hematological response.
- •6. Only for responder-group: Patient with hematological response defined according to the IWG criteria of 2006 which must last at least 8 weeks and confirmed by the scientific advisory committee.
- •7. Only for non-responder group: confirmation by the scientific advisory committee that patient is eligible based on matched-pairing and confirmation of no hematological response. Minimal requirements for matched pairing include age, sex, IPSS score, hemoglobin level and transfusion need at baseline, treatment duration with deferasirox and time since MDS diagnosis. Pairing can be extended according to level of leukopenia, thrombocytopenia, serum ferritin level at baseline, comorbidities and transfusion history.
- •8.Bone marrow aspirate taken at the time of MDS diagnosis (at baseline) retrievable from patient’s hospital and viably frozen. This should be checked by the treating hematologist/oncologist before referring the patient for potential inclusion to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Known concomitant presence of anemia due to iron, B12 or folate deficiencies, auto-immune or hereditary hemolysis, gastro-intestinal bleeding, or medication induced anemia at the time of screening,
- •2. Known infection with viral hepatitis B (HBV) or hepatitis C (HCV) defined as the presence in blood of HBV antigens in absence of HB antibodies, or presence of HCV antibodies at the time of screening,
- •3. Known positivity to human immunodeficiency virus (HIV) measured by enzyme-linked immunosorbent assay (ELISA) or western blot at the time of screening,
- •4. Patient participating in another clinical trial or receiving an investigational drug, within 1 month prior to study inclusion
- •5. History of other malignancy within the last five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
- •6. Concomitant treatment with other drugs known or suspected to elicit hematological response (azacitidine, erythroid stimulating agents, granulocyte colony stimulating factors, lenalidomide, thalidomide, valproate, ATG, cyclosporine, arsenic trioxide). When patients are still receiving red blood cell transfusions, patients are still eligible for study inclusion as long as they meet the IWG criteria of 2006
- •7. Female patients who are pregnant or breast feeding.
- •1. Known concomitant presence of anemia due to iron, B12 or folate deficiencies, auto-immune or hereditary hemolysis, gastro-intestinal bleeding, or medication induced anemia at the time of screening,
- •2. Known infection with viral hepatitis B (HBV) or hepatitis C (HCV) defined as the presence in blood of HBV antigens in absence of HB antibodies, or presence of HCV antibodies at the time of screening,
- •3. Known positivity to human immunodeficiency virus (HIV) measured by enzyme-linked immunosorbent assay (ELISA) or western blot at the time of screening,
- •4. Patient participating in another clinical trial or receiving an investigational drug, within 1 month prior to study inclusion
- •5. History of other malignancy within the last five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
- •6. Concomitant treatment with other drugs known or suspected to elicit hematological response (azacitidine, erythroid stimulating agents, granulocyte colony stimulating factors, lenalidomide, thalidomide, valproate, ATG, cyclosporine, arsenic trioxide). When patients are still receiving red blood cell transfusions, patients are still eligible for study inclusion as long as they meet the IWG criteria of 2006
- •7. Female patients who are pregnant or breast feeding.
- •1. Known concomitant presence of anemia due to iron, B12 or folate deficiencies, auto-immune or hereditary hemolysis, gastro-intestinal bleeding, or medication induced anemia at the time of screening,
- •2. Known infection with viral hepatitis B (HBV) or hepatitis C (HCV) defined as the presence in blood of HBV antigens in absence of HB antibodies, or presence of HCV antibodies at the time of screening,
- •3. Known positivity to human immunodeficiency virus (HIV) measured by enzyme-linked immunosorbent assay (ELISA) or western blot at the time of screening,
- •4. Patient participating in another clinical trial or receiving an investigational drug, within 1 month prior to study inclusion
- •5. History of other malignancy within the last five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
- •6. Concomitant treatment with other drugs known or suspected to elicit hematological response (azacitidine, erythroid stimulating agents, granulocyte colony stimulating factors, lenalidomide, thalidomide, valproate, ATG, cyclosporine, arsenic trioxide). When patients are still receiving red blood cell transfusions, patients are still eligible for study inclusion as long as they meet the IWG criteria of 2006
- •7. Female patients who are pregnant or breast feeding.
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