A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Completed · Phase 3
Conditions studied: Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
In brief
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Key facts
- Study ID
- NCT01578707
- Run by
- Pharmacyclics LLC.
- People needed
- 391
- Starts
- 2012-06-01
- Expected to finish
- 2018-10-25
- Last updated by the study team
- 2019-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 transplant within 6 months prior to first dose of study drug.
- Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
- 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.
Where it is running
- Site #377 — Los Angeles, California, United States
- Site #403 — Santa Maria, California, United States
- Site #038 — Stanford, California, United States
- Site #411 — Norwalk, Connecticut, United States
- Site #107 — Marietta, Georgia, United States
- Site # 379 — Evansville, Indiana, United States
- Site # 390 — Boston, Massachusetts, United States
- Site # 391 — Boston, Massachusetts, United States
- Site # 349 — Boston, Massachusetts, United States
- Site # 130 — Detroit, Michigan, United States
- Site # 406 — Rochester, Minnesota, United States
- Site # 059 — New Brunswick, New Jersey, United States
- Site # 350 — New Hyde Park, New York, United States
- Site # 200 — New York, New York, United States
- Site # 127 — Rochester, New York, United States
- Site # 197 — Cincinnati, Ohio, United States
- Site # 217 — Columbus, Ohio, United States
- Site # 402 — Philadelphia, Pennsylvania, United States
- Site # 396 — Greenville, South Carolina, United States
- Site # 410 — Nashville, Tennessee, United States
- Site # 032 — Houston, Texas, United States
- Site # 381 — Laredo, Texas, United States
- Site # 210 — Charlottesville, Virginia, United States
- Site # 404 — Seattle, Washington, United States
- Site #408 — La Jolla, California, United States
Full record on ClinicalTrials.gov
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