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

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2011-005474-38-BE
• Date of registration: 12/12/2011
• Prospective Registration: Yes
• Primary sponsor: Institut Jules Bordet
• Public title: The use of isotope-bound antibodies to visualize and subsequently treat B-cell lymphoma
• Scientific title: 89Zr-Rituximab PET/CT-Imaging and Dosimetry and 90Y-Rituximab Radioimmunotherapy in CD20+ B-Cell lymphoma - YZIRIT
• Date of first enrolment: 08/03/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005474-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium

Contacts

• Name: Vaes Mélanie
• Affiliation: Institut Jules Bordet

• Name: Vaes Mélanie
• Affiliation: Institut Jules Bordet

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CD20 positive Lymphoma
MedDRA version: 14.0 Level: PT Classification code 10003902 Term: B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: 89Zr-N-sucDf-rituximab
Product Code: none
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 89Zr-SucDf-Rituximab
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: range
Concentration number: 0.9-7.2

Product Name: 90Y-DOTA-rituximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 90Y-DOTA-rituximab
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: range
Concentration number: 50-100

Primary Outcome(s)

Main Objective: Evaluation of safety of Zirconium-89 (89Zr)- rituximab chimeric anti-CD20 antibody for PET/CT imaging and dosimetry.
Evaluation of safety of Yttrium-90 (90Y)-rituximab chimeric anti-CD20 antibody radioimmunotherapy in patients with B-cell lymphoma who are in partial remission or progressive disease

Timepoint(s) of evaluation of this end point: Weekly evaluation of the toxicity during first 3 months
Evaluation of late toxicity every 3 months during 2 years follow-up

Primary end point(s): Evaluation of safety of Zirconium-89 (89Zr)- rituximab chimeric anti-CD20 antibody for PET/CT imaging and dosimetry.

Evaluation of safety of Yttrium-90 (90Y)-rituximab chimeric anti-CD20 antibody radioimmunotherapy in patients with B-cell lymphoma who are in partial remission or progressive disease

Secondary Objective: -Evaluation of the efficacy of 90Y-rituximab treatment by assessment of metabolic response status (by FDG-PET/CT-imaging) and progression-free survival.

-Evaluation of the efficacy of 89Zr-rituximab PET/CT-imaging

-Evaluation of a voxel based dosimetry model based on PET/CT imaging using 89Zr-rituximab

-Diagnostic comparison of 89Zr-rituximab-PET/CT with FDG-PET/CT

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: -Response assessment by FDG-PET three months after administration of the treatment
- other end points will be evaluated at the end of the study with an interim analysis 2 years after the inclusion of the first patient

Secondary end point(s): -Evaluation of the efficacy of 90Y-rituximab treatment by assessment of metabolic response status (by FDG-PET/CT-imaging) and progression-free survival.

-Evaluation of the efficacy of 89Zr-rituximab PET/CT-imaging

-Evaluation of a voxel based dosimetry model based on PET/CT imaging using 89Zr-rituximab

-Diagnostic comparison of 89Zr-rituximab-PET/CT with FDG-PET/CT

-Evaluation of the influence of infusion of unlabelled (cold) rituximab on the distribution of the radio-immunoconjugate

Secondary ID(s)

YZIRIT

Source(s) of Monetary Support

FNRS - Télévie

Les Amis de Bordet

National Cancer Plan