To compare the safety and efficacy of the relapsed diffuse large B cell lymphoma or grade 3b follicular lymphoma subject treated with Ofatumumab versus the same subject set treated with Rituximab

Phase 3

Conditions: Health Condition 1: null- Diffuse Large Cell B Cell Lymphoma or Grade 3b Follicular Lymphoma

Registration Number: CTRI/2012/06/002749

Lead Sponsor: GlaxoSmithKline Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

1 CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original diagnosis If

a biopsy or fine needle aspiration (FNA) is performed prior to enrolment to the

study it must confirm CD20 positive DLBCL or grade 3b FL Note If evidence

emerges that the binding of the immunohistochemical antibody to CD20 can be

blocked by rituximab demonstration of CD20 positivity in the repeat biopsy/FNA

will not be required

2 Refractory to or relapsed following first-line treatment with rituximab concurrently

with anthracycline- or anthracenedione-based chemotherapy

Refractory disease must fulfill one of the following

continuing partial response (PR) from termination of first-line treatment The

lymphoma should be reconfirmed by biopsy (preferred) or FNA however if

these procedures are deemed to be inappropriate, then HOVON may

determine eligibility following review of the imaging results and disease

history

Subjects must have received rituximab concurrently with at least 6 cycles of

chemotherapy However, subjects with stage I/II disease will be eligible if

they have received rituximab concurrently with at least 3 cycles of

chemotherapy and definitive involved-field radiation therapy

continuing stable disease (SD) from termination of first-line treatment

Reconfirmation of the lymphoma by biopsy (preferred) or FNA is

recommended but not mandatory

Subjects must have received rituximab concurrently with at least 3 cycles of

chemotherapy

progressive disease (PD) Biopsy or FNA reconfirmation of the lymphoma is

recommended but not mandatory

Note: Disease response to first-line treatment should be determined according to

Revised Response Criteria for Malignant Lymphoma [Cheson 2007] or

International Workshop Response criteria for NHL [Cheson 1999] For guidance on

the adequacy of dosing of rituximab during first-line therapy refer to the SPM

3 Baseline FDG-PET scans must demonstrate positive lesions compatible with CT

defined anatomical tumor sites

4 CT scan showing at least:

2 or more clearly demarcated lesions/nodes with a long axis >1.5cm and short

axis >=1.0cm

1 clearly demarcated lesion/node with a long axis >2.0cm and short axis

>=1.0cm.

5 Age >=18

6 ECOG performance status 0 1 or 2

7 Eligible for high dose chemotherapy and ASCT

8 Resolution of toxicities from first-line therapy to a grade that in the opinion of the

investigator does not contraindicate study participation

9 Signed written informed consent

Exclusion Criteria

1 Any previous cancer therapy for the lymphoma, with the exception of First-line treatment with rituximab and an anthracycline- or anthracenedionebased

chemotherapy

Monotherapy rituximab, dosed prior to first-line rituximab combined with

chemotherapy or as maintenance therapy

Radiotherapy as part of the first-line treatment plan

Radiotherapy to a limited field at a maximum dose of <=10Gy to control lifethreatening

symptoms

2 Received any of the following treatments within two weeks prior to start of study

therapy (unless otherwise stated)

Anti-cancer cytotoxics (e.g. alkylating agents anti-metabolites purine

analogues)

Radiotherapy unless it is to a limited field at a maximum dose of <=10Gy to

control life-threatening symptom

3 Treatment with any known non-marketed drug substance or experimental therapy

within 5 terminal half lives or 4 weeks prior to enrollment whichever is longer or

currently participating in any other interventional clinical study unless in the opinion

of the investigator it does not contraindicate participation in this study

4 Planned post-randomisation glucocorticoid therapy unless

specified by the protocol

administered in doses <=1mg/kg/day prednisolone (or equivalent dose of other

glucocorticoid-refer to the SPM for glucocorticoid equivalent doses)

administered as inhalation therapy for mild COPD or asthma

5 History of significant cerebrovascular disease or event with significant symptoms or

sequelae unless in the opinion of the investigator it does not contraindicate

participation in the study

6 Clinically significant cardiac disease including unstable angina acute myocardial

infarction within six months prior to randomisation congestive heart failure (NYHA

III-IV) and arrhythmia unless controlled by therapy with the exception of extra

systoles or minor conduction abnormalities, unless in the opinion of the investigator

it does not contraindicate participation in the study

7 Significant concurrent, uncontrolled medical condition that in the opinion of the

investigator contraindicates participation in this study

8 Known lymphoma involvement of the CNS

9 Known or suspected hypersensitivity to study treatments that in the opinion of the

investigator contraindicates their participation

10 Known HIV positivity

11 Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg In

addition if negative for HBsAg but HBcAb positive (regardless of HBsAb status) a

HB DNA test will be performed and if positive the subject will be excluded

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method