EFFECTS OF THREE TREATMENT STRATEGIES ON ANEMIA AND QUALITY OF LIFE IN PATIENTS WITH SOLID TUMORS OR LYMPHOPROLIFERATIVE MALIGNANCIES: A RANDOMIZED 3-ARM STUDY ON ACTIVE (A) OR CONVENTIONAL (C) TRANSFUSIONS OR EPOETIN BETA (E). THE ACE STUDY. - ACE

Roche AB0 个研究点目标入组 210 人开始时间: 2006年12月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Adult patients (age =18 years) with anemia and cancer of e.g. lung, breast, colorectum, prostate or cancer of gynecological origin; as well as patients with anemia and low grade lymphoma, B-chronic lymphatic leukemia or multiple myeloma.
•- Histologically and/or cytologically proven diagnosis
•- Transfusion requirement =2 units packed RBCs during the last 3 months prior to study treatment
•- Hb <100g/L at study entry
•- Anemia due to chemotherapy or cancer
•- Life expectancy > 4 months
•- WHO performance status grade 0-2
•- Written informed consent according to Helsinki declaration
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Relevant acute or chronic bleeding within 3 months prior to study treatment
•- Ongoing chemotherapy where cessation is planned to occur in the next eight weeks
•- Nonpalliative radiation therapy with curative intention as sole treatment
•- Therapy-resistant hypertension, diastolic BP >100 mmHg
•- Absolute iron deficiency (s-ferritin <100µg/L)
•- S-ferritin >1000µg/L
•- Thrombocytopenia: platelet count <20x109/L
•- Thrombocytosis: platelet count >500x109/L
•- S-Creatinine >175µmol/L
•- B12 deficiency (S-cobalamine < lower normal limit)
•- Folate deficiency (S-folate < lower normal limit)
•- Autoimmune hemolysis
•- Uncontrolled cardiac arrhythmias or heart failure
•- Angina pectoris when Hb <100g/L
•- Known allergy to any of the study medications
•- Pregnancy or lactation period
•- Unreliable contraception
•- Administration of any investigational drug to patient within 30 days preceding the first dose of the study drug or during trial.
•- Epoetin treatment in the last 3 months
•- Myelodysplastic syndrome (MDS) or head /neck cancer
•- Prior diagnosis of primary red cell disorders which cause anemia (i.e., hemoglobinopathy, pure red cell aplasia [PRCA])

发起方