HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

NCT00394836 | Completed Phase 2 Results DMC

• 2 other identifiers: 111772Hx-CD20-405
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma, Follicular

Keywords

ofatumumab; rituximab; NHL; CD20; refractory

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Objective Response (OR)

  OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass \>1.5 centimeters \[cm\] in its longest transverse diameter that regressed \>75% compared to baseline), or Partial Response (PR; \>=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.

  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)

  Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node \>1 cm), or Not Evaluable (NE) participants were classified as non-responders.

  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 (16)

• Duration of Response

  From start of treatment (Week 0) until Month 24

• Progression-Free Survival

  From start of treatment (Week 0) until Month 24

• Time to Next Follicular Lymphoma (FL) Therapy

  From start of treatment (Week 0) until Month 24

• Overall Survival

  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

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

Interventions

Ofatumumab DRUG

Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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; 405 Study Investigators. Ofatumumab monotherapy in rituximab-refractory follicular lymphoma: results from a multicenter study. Blood. 2012 Apr 19;119(16):3698-704. doi: 10.1182/blood-2011-09-378323. Epub 2012 Mar 2.

  PMID: 22389254 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2013
• Last Updated: January 29, 2014
• Results First Posted: December 8, 2011

Record last verified: 2013-11

Locations

GB (1)