Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Prolymphocytic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Richter Syndrome

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Ibrutinib

Ofatumumab

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing

In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)

In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily

PCI-32765

ofatumumab

Samantha Jaglowski, MD

The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases

Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL

An Open-label, Phase 1b/2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Prolymphocytic Leukemia

The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.

Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2

Number of participants who had experienced at least one treatment emergent AE

Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:

* Appearance of any new lesion, eg lymph nodes (\> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates
* Increase of ≥50%

  * in longest diameter of any previous site
  * in hepatomegaly or splenomegaly
  * in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen

Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:

* Appearance of a new lesion(s) \>1.5 cm in any axis, ≥ 50% increase in the SPD of \>1 node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis
* Lesions PET+ if FDG-avid lymphoma or PET+ before therapy
* 50% increase from nadir in the SPD of any liver or spleen lesions
* New or recurrent BM involvement
* Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen

Ohio State University

Pharmacyclics LLC.

Group 1

Group 2

Group 3

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Jutta K. Neuenburg

In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing

Percentage of Participants Achieving Response

Number of Participants With Treatment Emergent Adverse Events (AEs)

In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing

Progression Free Survival (PFS) at 12 Months

Safety During Dose-Limiting Toxicity (DLT) Observation Period

Overall Study

Spots Global Cancer Trial Database for Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial