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An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)


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

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Trial Information

An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)


Patients with CLL that is refractory to fludarabine have few treatment options and a poor
prognosis. There is a continued need for new therapies for these CLL patients, as
demonstrated by the limited responses and substantial toxicities with existing therapies.
This is supported by the lack of a consensus around standard of care treatment for CLL
patients with bulky fludarabine-refractory disease. The objective of this study is to
confirm the response rate and disease control in the refractory setting through a controlled
trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory,
bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients will
be further randomized to either extended ofatumumab treatment or observation. Patients on
the physicians' choice arm will have the option of receiving ofatumumab if they experience
progressive disease.


Inclusion Criteria:



- Adults with documented diagnosis of active CLL requiring treatment

- Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm

- Must be refractory to fludarabine treatment

- Age 18 yrs or older

- At least 2 prior therapies for CLL

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Signed written informed consent

Exclusion Criteria:

- Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant
within 6 months

- Treatment with any unapproved drug substance or experimental therapy within 4 weeks,
or currently participating in another interventional clinical study

- CLL transformation, prolymphocytic leukemia, or central nervous system (CNS)
involvement of CLL

- Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated
with progressive disease requiring anti-CLL treatment

- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment

- Human immunodeficiency virus (HIV) positive

- Significant concurrent, uncontrolled medical condition

- Other past or current malignancy (with the exception of basal cell carcinoma of the
skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully
treated with curative intent at least 2 years prior to trial entry

- Non-protocol corticosteroid usage except a maintenance dose corresponding to less
than or equal to 10 mg prednisone

- Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal
creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due
to liver involvement of CLL or due to Gilbert's syndrome), or alanine transaminase
(ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)

- Known or suspected hypersensitivity to ofatumumab

- 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: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Approximately 44 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Sweden: Centrala Etikprövningsnämnden

Study ID:

114242

NCT ID:

NCT01313689

Start Date:

April 2011

Completion Date:

March 2018

Related Keywords:

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

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