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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Objective Response (OR)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

111772

NCT ID:

NCT00394836

Start Date:

September 2006

Completion Date:

September 2013

Related Keywords:

  • Lymphoma, Follicular
  • ofatumumab
  • rituximab
  • NHL
  • CD20
  • refractory
  • Lymphoma
  • Lymphoma, Follicular

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