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A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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

NCT01578707•Pharmacyclics LLC.

View on ClinicalTrials.gov

Summary

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)

Detailed Description

Study PCYC-1112-CA is 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. Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.
+3 more criteria

Locations (76)

Site #408

La Jolla, California, United States

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

Key Dates

Start Date

June 1, 2012

Primary Completion Date

November 1, 2013

Completion Date

October 25, 2018

Last Updated

December 18, 2019

Enrollment

391

ACTUAL participants

Conditions

Relapsed or Refractory Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Interventions

ofatumumab

DRUG

ibrutinib

DRUG

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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RECRUITINGPHASE3

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT05254743

Chronic Lymphocytic LeukemiaLeukemia, Lymphocytic+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma