Monoclonal Antibodies in Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (MARALL)

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia
Interventions
BIOLOGICAL

humanised monoclonal antibody, veltuzumab

Veltuzumab with modified UKALL XII induction chemotherapy. Veltuzumab will be administered at 200 mg/m2 IV on Day 8 and subsequently, (if tolerated on Day 8), over 1 hour on Days 15, 22, 29.

BIOLOGICAL

humanised monoclonal antibody epratuzumab

Epratuzumab with modified UKALL XII induction chemotherapy. Epratuzumab will be administered at 360 mg/m2 IV over 1 hour on Days 8, 15, 22 and 29.

BIOLOGICAL

humanised monoclonal antibodies veltuzumab and epratuzumab

Epratuzumab + Veltuzumab with modified UKALL XII induction chemotherapy. Epratuzumab will be administered at 360 mg/m2 IV over 1 hour on Days 8, 15, 22 and 29. Veltuzumab will be administered at 200 mg/m2 IV over 2 hours on Day 8 and over 1 hour on Days 15, 22 and 29. Veltuzumab will be infused 1 hour after the infusion of epratuzumab.

Trial Locations (10)

B15 2TH

University Hospitals Birmingham NHS Foundation, Birmingham

BS2 8BJ

University of Bristol Foundation Trust, Bristol

CF14 4XN

University Hospital of Wales, Cardiff

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

EC1A 7BE

Barts and the London NHS Trust, London

NW3 2QG

Royal Free Hampstead NHS Trust, London

NE2 4HH

Newcastle University, Newcastle

NG5 1PB

Nottingham City Hospital, Nottingham

PL6 8DH

Plymouth Hospitals NHS Trust, Plymouth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Queen Mary University of London

OTHER