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

Vrije Universiteit Medisch Centrum0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- 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 methods.
•- 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.

•- 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

发起方