Clinical trial · Interventional
A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
A Randomized, Multicenter, Open-Label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 (Ibrutinib) Versus Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT01973387CI-TRIAL-00033936completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus rituximab in adult Asia Pacific region patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm A
- interventionNames
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Treatment Arm B
- interventionNames
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)
- description
- Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (\>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (\>=)50 percent (%) increase from nadir in existing lymph node or \>=50% increase from nadir in sum of product of diameters of multiple nodes; \>=50% increase from nadir in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group performance status of 0-1 * Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that meets protocol-defined criteria * Laboratory values within protocol-defined parameters * Active disease meeting International Workshop on Chronic Lymphocytic Leukemia 2008 criteria * Received at least 1 prior therapy for CLL/SLL and not appropriate for treatment or retreatment with purine analog-based therapy * Measurable nodal disease by computed tomography * Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and agree to use highly effective methods of contraception during the study and for 90 days following the last dose with ibrutinib or 12 months following the last dose of rituximab Exclusion Criteria: * Central nervous system lymphoma or leukemia * Prolymphocytic leukemia or history of or currently suspected Richter's transformation * Refractory to prior rituximab-based therapy * Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days prior to first dose of study drug * Corticosteroid use \>20 mg within 1 week prior to first dose of study drug * Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose of study drug * Prior autologous transplant within 6 months prior to first dose of study drug * Prior allogeneic stem cell transplant * Major surgery within 4 weeks prior to first dose of study drug * History of prior malignancy according to protocol-defined criteria * Currently active clinically significant cardiovascular disease within 6 months prior to first dose with study drug * Uncontrolled active systemic fungal, bacterial, viral, or other ongoing anti-infective treatment administered intravenously * History of human immunodeficiency virus or active infection with hepatitis B or C * History of stroke or intracranial hemorrhage within 6 months prior to random assignment * Pregnant or lactating women * Current life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, or put the study at risk * Requires or receiving anticoagulation with warfarin or equivalent Vitamin K antagonists * Requires treatment with a strong CYP3A4/5 inhibitor * Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (greater than \[\>\]20 milligram \[mg\] daily of prednisone daily or equivalent)
References
Publications (0)
Data not yet available
No reference posted for this study.