S10BEOF01

CLinical Organization for Strategies and Solutions S.r.l. - CLIOSS S.r.l.

Viale Pasteur 10, Nerviano (Mi), Italy, 20014

Direzione Scientifica, CLIOSS Srl, 0039 0331581482, cristina.davite@clioss.com

Direzione Scientifica, CLIOSS Srl, 0039 0331581482, cristina.davite@clioss.com

No

No

No

Final

03 May 2017

Yes

26 Sep 2016

Yes

26 Sep 2016

No

To evaluate the efficacy (Overall Remission Rate) of ofatumumab and bendamustine in relapsed or refractory marginal zone B-cell lymphomas

Study Protocol foresees that therapies considered necessary for the patient's well being might be given at the discretion of the Investigator, i.e. chronic treatments for concomitant medical conditions, as well as agents required for life-threatening medical problems.

13 Mar 2012

No

No

Switzerland: 8

Italy: 8

16

8

0

0

0

0

0

0

9

7

0

Overall trial (overall period)

Not applicable

OFATUMUMAB

GSK1841157

NA

Concentrate for solution for infusion

Intravenous use

Patients were treated with Ofatumumab iv 1000 mg on day 1 every 28 days for 6 cycles. The initial rate of the first infusion of 1000 mg ofatumumab (1 mg/mL) had to be 12 mL/h. If no infusion reactions occurred the infusion rate had to be increased every 30 minutes, to a maximum of 400 mL/h. If an infusion reaction developed, the infusion had to be temporarily slowed or interrupted. If the previous infusion were completed without grade ≥ 3 infusion-associated AEs, the subsequent infusion of the 1000 mg ofatumumab (1 mg/mL) could start at a rate of 25 mL/h and had to be doubled every 30 minutes up to a maximum of 400 mL/h.

BENDAMUSTINE HYDROCHLORIDE

NA

NA

Powder and solvent for solution for infusion

Intravenous use

Bendamustine 90 mg/m2 was administered on days 1 and 2 by iv infusion over 30-60 minutes. I

Arm 1

Arm 1

Evaluable patients

Efficacy Evaluable (EE) population defined as all treated patients, with no major deviations from the eligibility criteria affecting efficacy evaluation, for whom the tumor response could be evaluated at least once while on treatment. These patients should have received at least 2 cycles after treatment starts, unless disease progression occurred at cycle 1.

Overall Remission Rate (ORR) was defined as the percentage of patients with a CR or PR as per Cheson criteria (2007) . For patients with splenic MZL response was defined according to Matutes et al. (2008) and for patients with gastric lymphomas histological response was evaluated according to GELA scoring system (Copie-Bergman et al 2003). A patient with unknown or missing response was to be treated as a non-responder, i.e., the patient was to be included in the denominator when calculating the percentage. Exact methods for calculated confidence intervals were to be utilized.

Primary

CT-scan at the end of cycle 2 and at FU1 (4 months), FU2 (8 months) and FU3 (24 months) after the end of treatment.

Progression Free Survival was defined as the time from the first treatment administration to documentation of disease progression, start of a new antitumor therapy or death (for any cause). Patients not known to have progressed or started a new antitumor therapy or died (for any cause) were to be censored for PFS at the time of last tumor assessment.

Secondary

Two years after the end of the treatment.

Duration of Response was defined, for the subset of patients with a CR or PR, as the time from when criteria for response were first met until first documented relapse or progression or death due to any cause. If sample size permitted, duration of response had to be summarized descriptively using Kaplan-Meier medians and quartiles. Only the subset of patients who showed a CR or PR were to be included in this summary.

Secondary

Time to relapse.

During all study period and followed until 28 days following the last dose of investigational product.

Drug-related and serious adverse events ongoing at the end of this observation period had to be recorded until they were resolved or the investigator assessed them as chronic or the subject was lost to follow-up or started a new anti-cancer treatment, whichever occurred earlier.

20

Arm 1