Safety and tolerability of the combination of veltuzumab and epratuzumab with intensive chemotherapy in patients with relapsed B-cell acute lymphoblastic leukaemia (ALL)

Phase 1

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute lymphoblastic); Cancer; Acute lymphoblastic leukaemia

• Registration Number: ISRCTN15257573
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Study Completion: 2011-10-09
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Aged between 16 and 65 years, either sex
2. Confirmed diagnosis of first recurrence of B-precursor ALL (according to the World Health Organization [WHO] classification)
3. First complete remission (CR1) greater than 6 months
4. WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and well enough to receive intensive combination chemotherapy
5. 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 amenorrhoic for at least 24 months.
6. Patients must have a cardiac ejection fraction of greater than 50%
7. Patients must have adequate organ function:
7.1. Renal function ? serum creatinine less than 2.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) greater than 50 ml/min (measured EDTA or estimated creatinine clearance, e.g., Cockcroft & Gault)
7.2. Liver function - bilirubin/alanine aminotransferase (ALT) less than 2.5 x ULN
8. Patients must be able to comply with the study schedule

Exclusion Criteria

1. Patients with Philadelphia positive (Ph +ve) ALL
2. Patients at 2nd or greater relapse of their ALL
3. Patients should not have received chemotherapy for relapsed ALL (except corticosteroids for a maximum of 5 days, before joining the study)
4. Patients who have already received greater than 340 mg/m^2 daunorubicin (or equivalent total anthracycline dose) therapy
5. Patients who have received prior mediastinal radiotherapy
6. 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
7. Patients with severe psychiatric disorders which in the PI's opinion makes them unsuitable for trial participation
8. 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 post-menopausal (that is amenorrheic for 24 months).
9. Females of childbearing potential must have a negative pregnancy test within 7 days prior to starting the study
10. Females must not be breastfeeding
11. Patients may not receive any other investigational agent during the study
12. Patients should not have received any antibody therapy within 9 months of joining this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of the combination of veltuzumab and/or epratuzumab with intensive chemotherapy for recurrent adult B-precursor ALL by scoring dose limiting toxicity events in patients.

Secondary Outcome Measures

Name	Time	Method
Achievement of morphological and molecular complete remission on Day 29 bone marrow