The use of isotope-bound antibodies to visualize and subsequently treat B-cell lymphoma

• Conditions: CD20 positive Lymphoma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.0Level: PTClassification code 10003902Term: B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-005474-38-BE
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed (according to the REAL/WHO classification) CD20 positive lymphomas

•Patients with a PR or PD

•Failed at least one regimen of standard treatment/chemotherapy

•Age 18 years or older

•World Health Organization (WHO) performance status of 0 to 2

•Absolute Neutrophil Count (ANC) of 1.5 x 109/L or higher

•Haemoglobin (Hb) of 9 g/dl or higher

•Platelet count of 100 x 109/L or higher

•Life expectancy of at least 6 months

•Written informed consent obtained according to local guidelines

•For patients with = 3 prior cytotoxic treatment regimens and/or patients previously treated with stem cell transplantation, a bone marrow or peripheral blood stem cell harvest is mandatory to rescue unexpected marrow toxicity from the procedure.

Are the trial subjects under 18? no
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Patients who have not recovered from the toxic effects of previous treatment

•Any other uncontrolled malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma

•Patients with known HIV positivity

•Patients who are positive for HCV, HbsAG or other active infection uncontrolled by treatment

•Patients with abnormal liver function: total bilirubin > 2 x ULN or ALT > 3 x ULN

•Patients with abnormal renal function: serum creatinine> 2 x ULN

•Known anti-chimeric antibody (HACA) reactivity or hypersensitivity to murine antibodies or proteins

•Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test at study entry)

•Concurrent severe and/or uncontrolled medical disease (ie. uncontrolled diabetes, conges¬tive heart failure, myocardial infarction within 6 months of the study, unstable and uncon¬trolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.

•Patients who received investigational drugs less than 4 weeks before entry in this study or who have not as yet recovered from the toxic effects of such therapy

•Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment

•Patients with a history of psychological illness or condition which could interfere with his ability to understand the requirements of the study (this includes alcoholism/drug addiction)

•Patients unwilling or unable to comply with the protocol

Study & Design

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