Phase I/II Study combining humanised anti-CD20 (veltuzumab), anti-CD22 (epratuzumab) and both monoclonal antibodies with chemotherapy in adults with recurrent B precursor acute lymphoblastic leukaemia (ALL)- MARALL - Monoclonal Antibodies In Recurrent B cell ALL (MARALL)

Queen Mary Medical University of London0 个研究点目标入组 27 人开始时间: 2009年6月26日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1. Aged over 16 years.
•2. Confirmed diagnosis of recurrence of B-precursor ALL [according to the WHO
•classification].
•3. WHO/ECOG performance status of 0-2 and well enough to receive combination
•chemotherapy.
•4. Negative pregnancy test in women of childbearing potential. Women will not be
•considered of child bearing potential if they have undergone surgical removal of
•the uterus or are post menopausal and have been amenorrheic for at least 24
•5. Patients must have adequate organ function:
•a. Renal function – serum creatinine <2.5 x ULN or eGFR>50ml/min
•(measured EDTA or estimated creatinine clearance e.g Cockcroft & Gault)
•b. Liver function (bilirubin/ALT <2.5 x ULN)
•6. Patients must be able to comply with the study schedule.
•Are the trial subjects under 18? yes
•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

•1) Patients with Philadelphia positive (Ph +ve) ALL who have not received a tyrosine
•kinase inhibitor or who have molecular or cytogenetic relapse..
•2) Patients should not have received chemotherapy for this current episode of
•relapsed ALL (except corticosteroids for a maximum of 5 days, before joining the
•3) Patients with co-morbidities: e.g. uncontrolled hypertension and or poorly
•controlled diabetes which in the PI’s opinion makes them unsuitable for the study.
•4) Patients with severe psychiatric disorders which in the PI’s opinion makes them
•unsuitable for trial participation.
•5) Females of childbearing potential and all males must be willing to use an effective
•method of contraception (hormonal or barrier method of birth control; abstinence)
•for the duration of the study and for up to 3 months after the last dose of study
•medication. Note: Subjects are not considered of child bearing potential if they are
•surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or
•bilateral oophorectomy) or they are postmenopausal (that is amenorrheic for 24
•6) Females of childbearing potential must have a negative pregnancy test within 7
•days prior to starting the study.
•7) Females must not be breastfeeding.
•8) Patients may not receive any other investigational agent during the study.
•9) Patients should not have received any antibody therapy within 9 months of
•joining this study.

发起方

Queen Mary Medical University of London