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A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukaemia, Lymphocytic, Chronic

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Trial Information

A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia


Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia.
Studies have shown that drugs in combination with fludarabine have shown more effectiveness
than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide
combination offers potentially a more effective therapy, without additional toxicity.

The objective of this study is to determine the effect of ofatumumab added to fludarabine
and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded
previously to therapy but later develop progressive disease and require additional therapy.


Inclusion Criteria:



- confirmed and active CLL requiring treatment

- at least one previous treatment for CLL and having achieved a complete or partial
remission/response but after a period of 6 or more months, shows evidence of disease
progression

- fully active at a minimum or fully capable of selfcare and up and about more than 50%
of waking hours

- age 18yrs or older

- signed written informed consent

Exclusion Criteria:

- diagnosis of refractory CLL (failure to achieve a complete or partial
remission/response or disease progression within 6 months of last anti-CLL treatment

- abnormal/inadequate blood values, liver and kidney function

- certain heart problems, serious significant diseases, AIHA, other current cancers or
within the last 5 years

- active or chronic infections

- use of drugs to suppress allergic or inflammatory responses (glucocorticoids)

- CLL transformation

- CLL central nervous system involvement

- current participation in other clinical study

- inability to comply with the protocol activities

- lactating or pregnant women or female patients of child-bearing potential (or male
patients with such partners) not willing to use adequate contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free-survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Institutional Review Board

Study ID:

110913

NCT ID:

NCT00824265

Start Date:

March 2009

Completion Date:

September 2017

Related Keywords:

  • Leukaemia, Lymphocytic, Chronic
  • Relapsed
  • Oncology
  • Safety
  • Chronic Lymphocytic Leukemia
  • Ofatumumab
  • Efficacy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteGermantown, Tennessee  38138