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A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Inclusion Criteria:



- ECOG performance status of 0-1.

- Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.

- Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.

- Must have received at least one prior therapy for CLL/SLL.

- Considered not appropriate for treatment or retreatment with purine analog based
therapy.

- Measurable nodal disease by CT.

- Patients must be able to receive outpatient treatment and laboratory monitoring at
the institution that administers study drug for the entire study.

Exclusion Criteria:

- Known CNS lymphoma or leukemia.

- No documentation of cytogenetic and/or FISH in patient records prior to first dose
of study drug.

- Any history of Richter's transformation or prolymphocytic leukemia.

- Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia
purpura (ITP).

- Prior exposure to ofatumumab or to ibrutinib.

- Prior autologous/allogeneic transplant

- History of prior malignancy, with the exception of certain skin cancers and
malignancies treated with curative intent and with no evidence of active disease for
more than 3 years.

- Serologic status reflecting active hepatitis B or C infection.

- Unable to swallow capsules or disease significantly affecting gastrointestinal
function.

- Uncontrolled active systemic fungal, bacterial, viral, or other infection.

- History of stroke or intracranial hemorrhage within 6 months prior to the first dose
of study drug.

- Requires anticoagulation with warfarin.

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:

PFS (Progression Free Survival)

Outcome Time Frame:

Analysis will be conducted after observing approximately 234 PFS events

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-1112-CA

NCT ID:

NCT01578707

Start Date:

June 2012

Completion Date:

December 2015

Related Keywords:

  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Chronic
  • SLL
  • CLL
  • Ofatumumab
  • ibrutinib
  • RESONATE
  • Phase III
  • Leukemia
  • Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

The Ohio State UniversityColumbus, Ohio  43210