A comparison of plerixafor/G-CSF with chemotherapy/G-CSF for stem cell transplantation - PHANTASTIC

Royal Liverpool and Broadgreen University Hospitals NHS Trust0 个研究点目标入组 100 人开始时间: 2010年6月28日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•All referrals to the transplant programme at our hospital are invariably seen by one of the investigators. All eligible patients will be offered entry into the trial at that initial visit.
•Inclusion criteria; all of the following must be satisfied:
•Aged 18 or over
•Able to give informed written consent.
•Diagnosis of EITHER multiple myeloma or related plasma cell dyscrasia, OR any form of lymphoma or associated lymphoproliferative disease
•Autologous stem cell transplantation is planned as the next course of treatment.
•The patient has not previously undergone a mobilisation attempt for the current transplant. Patients who have received previous autologous transplants at least 2 years previously are eligible, as long as stem cell mobilisation has not been attempted for the current transplant.
•No serious concomitant illness (e.g. heart disease) that might preclude completion of the study.
•Creatinine clearance of at least 30 mls/min. Dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min.
•Negative pregnancy test in women of childbearing age.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Exclusion criteria are ANY of the following:
•Unable to give informed written consent
•Pregnancy or lactating
•Creatinine clearance of less than 30 mls/min. Patients with clearances lower than this may still be able to receive plerixafor at reduced dosage following discussion with the trial co-ordinators, but are not eligible for entry into this trial.
•Any previous attempt at mobilisation for the current transplant.
•Patients with any form of leukaemia, INCLUDING PLASMA CELL LEUKAEMIA, are not eligible.

发起方

Royal Liverpool and Broadgreen University Hospitals NHS Trust