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 MedDRA version: 9.1 Level: LLT Classification code 10003917
Conditions
Interventions
Product Name: veltuzumab
Product Code: IMMU-106 or hA20
Pharmaceutical Form: Intravenous infusion
CAS Number: 728917-18-8
Current Sponso
Sponsors
Queen Mary Medical University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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 50ml/min (measured EDTA or estimated creatinine clearance e.g Cockcroft & Gault) b. Liver function (bilirubin/ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the safety and tolerability of the combination of veltuzumab and /or epratuzumab with chemotherappy for recurrent adult B-precursor acute lymphoblastic leukaemia; Secondary Objective: Achieving morphological CR on Day 29 bone marrow For patients enrolling for the optional minimal residual disease (MRD) research, the evaluation of efficacy of the treatment at achieving MRD negativity and investigation for an association between intensity of CD20 and CD22 antigen expression and treatment efficacy. ; Primary end point(s): The primary endpoint of the study is safety, measured by the number of dose-limiting toxicities (DLTs) and tolerability of both veltuzumab and epratuzumab given in combination with UKALL XII chemotherapy. The NCI CTCAE version 4.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. In this study, dose limiting toxicity (DLT) is defined as any treatment related:- • Anaphylaxis, symptomatic bronchospasm or other hypersensitivity reactions • Serious cardiac arrhythmias or cardiopulmonary events • Any Grade 3 or 4 non haematological toxicity not resolving within 28 days • Grade 2 autoimmune reactions, including development of anti-nuclear antibodies • Grade 2 asymptomatic bronchospasm or generalised urticaria. | — |
Countries
United Kingdom
Outcome results
None listed