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A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's

Thank you

Trial Information

A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma


Key

Inclusion Criteria:



Key

Inclusion Criteria:



- Aged >= 18 years old at the time of informed consent.

- Histologically confirmed follicular Grade 1-3a NHL.

- Relapsed or progressive disease after at least 1 prior chemotherapy requiring
treatment.

- Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single
dimension.

- Acceptable hematologic, hepatic, and renal function parameters.

- Recovered fully from any significant toxicity associated with prior surgery,
radiation treatments, chemotherapy, biological therapy, autologous bone marrow or
stem cell transplant, or investigational drugs.

Key Exclusion Criteria:

- Follicular lymphoma Grade 3b.

- Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to
prior rituximab or prior rituximab-containing regimen, or a response with a TTP of
less than 6 months).

- Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to
Study Day 1 (6 weeks if nitrosourea or mitomycin C).

- Prior lymphoma vaccine therapy within 12 months prior to Study Day 1.

- Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months
prior to Study Day 1.

- Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1.

- Prior allogeneic transplant.

- Transfusion-dependent subjects.

- Another primary malignancy requiring active treatment (except hormonal therapy).

- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active
uncontrolled bacterial, viral, or fungal infections; or other conditions, which would
compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

- New York Heart Association Class III or IV cardiac disease or myocardial infarction
within 6 months prior to Study Day 1.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.

Outcome Time Frame:

The duration of this study is approx 4 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

114-NH-301

NCT ID:

NCT00363636

Start Date:

September 2006

Completion Date:

April 2010

Related Keywords:

  • Lymphoma, Non-Hodgkin's
  • relapsed
  • NHL
  • pharmacokinetics
  • antibody
  • safety
  • galiximab
  • efficacy
  • rituximab
  • refractory
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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