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)

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10003917 Term: B-cell type acute leukaemia; This is a phase I/ II trial to determine the efficacy of intravenous veltuzumab and epratuzmab either individually or together in combination with chemotherapy in patients with recurrent acute lymphoblastic lymphoma.; MedDRA version: 9.1 Level: LLT Classification code 10003890 Term: B precursor type acute leukaemia

• Registration Number: EUCTR2008-002286-32-GB
• Lead Sponsor: Queen Mary Medical University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-26
• Study Completion: 2014-10-10
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

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
months.
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

Exclusion Criteria

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
study).
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
months).
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified