EUCTR2008-002195-10-NL进行中（未招募）1 期
A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome. - HOVON 89 MDS
HOVON Foundation0 个研究点目标入组 170 人开始时间: 2008年12月31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
- 入组人数
- 170
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
- •- Patients with MDS classified as
- •- RA, RARS and RAEB (with <10% myeloid blasts), CMML (with <10% myeloid
- •blasts), according to FAB or
- •- RA, RARS, RCMD, RCMD-RS, RAEB-1, MDS-U according to WHO or
- •- patients with MPD/MDS (CMML-1 according to WHO) with a WBC = 12x109/l
- •with an IPSS = 1.0
- •- Hb = 6.2 mmol/l (10.0 g/dl)
- •or Hb = 7.2 mmol/l and ANC = 1.0x109/l
- •or red blood cell transfusion dependent
- •- Age = 18 years
- •- WHO performance status 0-2
- •- Patient not previously treated with Epo/G-CSF, or
- •failure of response or relapse after hematological improvement or disease
- •progression to maximal RAEB-1 after previous therapy with Epo/G-CSF
- •- Serum creatinin < 150 µmol/l
- •- Serum billirubin < 25 µmol/l and ASAT, ALAT and Alkaline phosphatase < 2.5 times
- •the upper limit of normal, except if related to disease
- •- The patient must give written informed consent
- •- Negative pregnancy test within 7 days prior to start of study drug, if applicable.
- •- Patient (all men, pre-menopausal women) agrees to use adequate contraceptive
- •- Serum erythropoietin level
- •> 200 U/l or
- •= 200 U/l if failure of response or loss of hematological improvement or disease
- •progression to maximal RAEB-1 after prior standard therapy with Epo/G-CSF;
- •Epo/G-CSF should be stopped at least 1 month before randomization.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies.
- •- Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH)
- •- Hypoplastic MDS
- •- High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines
- •- Active uncontrolled infection
- •- Absolute neutrophil count (ANC) < 0.5x109/l
- •- Patients dependent on platelet transfusions or with platelet counts < 25x109/l or patients with active bleeding
- •- Patients treated with biological response modifiers (i.e. growth factors, immunosuppressive agents and/or chemotherapy) within 1 month prior to randomization
- •- Lactating women
- •- Prior treatment with lenalidomide
- •- Prior CTCAE = grade 3 allergic reaction/hypersensitivity to thalidomide
- •- Prior CTCAE = grade 3 rash/blistering while taking thalidomide
- •- Prior CTCAE = grade 3 allergic/hypersensitivity to Epo and/or G-CSF
研究者
相似试验
已完成
2 期
A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndromeMDS10024324myelodysplastic syndromeNL-OMON47453Vrije Universiteit Medisch Centrum200
尚未招募
2 期
A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >= 66 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patientsmyelodysplastic syndromes10024324Acute myeloid leukemiaNL-OMON53140HOVO70
进行中（未招募）
1 期
A randomized study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine treatment in patients with AML and high risk myelodysplasia (MDS), UNFIT for intensive chemotherapy. ,EUCTR2018-000047-31-NLHOVON Foundation140
已完成
2 期
A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients.myelodysplastic syndromes10024324Acute myeloid leukemiaNL-OMON55438HOVO88
进行中（未招募）
1 期
A randomized study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine treatment in patients with AML and high risk myelodysplasia (MDS), UNFIT for intensive chemotherapy, aged >= 66 years.Acute Meyloid Leukemia and High Risk Myelodysplastic syndromesMedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-002855-85-BEHOVON Foundation170