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HuMax-CD20 in Follicular Lymphoma (FL) Patients Refractory to Rituximab
This study is ongoing, but not recruiting participants.
First Received: October 31, 2006   Last Updated: June 17, 2010   History of Changes
Sponsor: GlaxoSmithKline
Collaborator: Genmab
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00394836
  Purpose

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


Condition Intervention Phase
Follicular Lymphoma
 Drug: Ofatumumab-HuMax-CD20
 Phase III

Study Type: Interventional
Study Design: Control: Uncontrolled
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab Ofatumumab
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy assessment [ Time Frame: 6 months after last treatment en then 3-6 months thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: September 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ofatumumab-HuMax-CD20
    Eight weekly infusions of ofatumumab. The first infusion of 300mg , followed by 7 weekly infusions of 1000 mg ofatumunab.
Detailed Description:

Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patient with follicular lymphoma grade 1 - 2

  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:

    1. failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
    2. disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
    3. 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)
  3. Tumor verified to be CD20+ positive from excisional lymph node biopsy

  4. CT scan in screening phase (based on local evaluation) showing:

    1. 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
    2. 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
  5. ECOG Performance Status of 0, 1, or 2
  6. Age ≥ 18 years
  7. 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

  1. Previous autologous stem cell transplantation within 6 months
  2. Previous allogeneic stem cell transplantation
  3. More than 1 previous radio immunotherapy regimen
  4. Received radio immunotherapy within 3 months
  5. Received any Anti-cancer treatment within 4 weeks
  6. Received monoclonal antibodies, other than rituximab within 3 months
  7. Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
  8. Life expectancy less than 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394836

  Show 49 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Genmab
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
ClinicalTrials.gov Identifier: NCT00394836     History of Changes
Other Study ID Numbers: Hx-CD20-405
Study First Received: October 31, 2006
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Follicular Lymphoma
refractory
rituximab
 ofatumumab
NHL
CD20

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 01, 2010



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