Last updated: 11/03/2018 12:11:10
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) patients refractory to rituximab

GSK study ID
111772
See study documents
Clinicaltrials.gov ID
NCT00394836
See results summary
EudraCT ID
2006-001433-17
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single-arm, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab as monotherapy or in combination with chemotherapy
Trial description: A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Not applicable
Primary outcomes:

Number of participants with objective response (OR)

Timeframe: Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)

Number of participants classified as responders and non-responders for objective response (OR)

Timeframe: 6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).

Secondary outcomes:

Duration of Response

Timeframe: From start of treatment (Week 0) until Month 24

Progression-Free Survival

Timeframe: From start of treatment (Week 0) until Month 24

Time to next follicular lymphoma (FL) therapy

Timeframe: From start of treatment (Week 0) until Month 24

Overall Survival

Timeframe: First dose (Week 0) until 5 years

Percent change from Screening (Visit 1) in tumor size as assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24

Timeframe: Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)

Percent change from Baseline (Visit 2) in CD19+ and CD20+ cells in peripheral blood at Visits 11 and 12

Timeframe: Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)

Number of participants with conversion and no conversion of BCL2 positive to BCL2 negative in peripheral blood

Timeframe: Screening (Visit 1) until Month 24 (Visit 18)

Number of participants who experienced any adverse event from first treatment (Visit 2) to Visit 18 (Month 24)

Timeframe: From first treatment (Visit 2) until Visit 18 (Month 24)

Number of participants with positive human anti-human antibodies (HAHA) at Visits 1, 12, 13, and 14

Timeframe: Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)

Complement (CH50) levels at Visit 1 and at the end of infusion at Visit 2

Timeframe: Visits 1 (Week -2) and 2 (Week 0)

Number of participants classified as responders for Fragment C Receptor (FcR) polymorphism (poly.)

Timeframe: From first treatment (Visit 2) until Visit 12 (Month 6)

Ctrough and Cmax at the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

AUC(0-inf) and AUC(0-168) after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

t1/2 after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

CL after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

Vss after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; to up 10 months after dose)

Interventions:
Drug: Ofatumumab
Enrollment:
116
Observational study model:
Not applicable
Primary completion date:
2009-21-04
Time perspective:
Not applicable
Clinical publications:
Czuczman MS, Fayad L, Delwail V, Cartron G, Jacobsen E, Kuliczkowski K, Link BK, Pinter-Brown L, Radford J, Hellmann A, Gallop-Evans E, DiRienzo CG, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Schultz M, Russell CA, Hagenbeek A . Ofatumumab Monotherapy in Rituximab-Refractory Follicular Lymphoma: Results from a Multicenter Study . [Blood]. 2012;119(16):3698-3704.
Medical condition
Lymphoma, Follicular
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
May 2007 to May 2013
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion Criteria
  • Patient with follicular lymphoma grade 1 – 2
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria
  • Patient with follicular lymphoma grade 1 – 2
  • Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
  • failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
  • disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
  • disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
  • Tumor verified to be CD20+ positive from excisional lymph node biopsy
  • CT scan in screening phase (based on local evaluation) showing:
  • 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
  • 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
  • ECOG Performance Status of 0, 1, or 2
  • Age ≥ 18 years
  • Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out Exclusion Criteria
  • Previous autologous stem cell transplantation within 6 months
  • Previous allogeneic stem cell transplantation
  • More than 1 previous radio immunotherapy regimen
  • Received radio immunotherapy within 3 months
  • Received any Anti-cancer treatment within 4 weeks
  • Received monoclonal antibodies, other than rituximab within 3 months
  • Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
  • Life expectancy less than 6 months

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
No longer a GSK study
Actual primary completion date
2009-21-04
Actual study completion date
2013-23-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website