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A Multicenter, Open-label, Phase 2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects With Relapsed or Refractory or de Novo Diffuse Large B-cell Lymphoma (DLBCL)

Phase 2
18 Years
Open (Enrolling)
Diffuse Large Cell B-lymphoma

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Trial Information

A Multicenter, Open-label, Phase 2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects With Relapsed or Refractory or de Novo Diffuse Large B-cell Lymphoma (DLBCL)

Inclusion Criteria:

- Men and women ≥ 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- Pathologically confirmed de novo DLBCL; subjects must have available archival tissue
for central review to be eligible.

- Relapsed or refractory disease, defined as either: 1) recurrence of disease after a
complete remission (CR), or 2) partial response (PR), stable disease (SD), or
progressive disease (PD) at completion of the treatment regimen preceding entry to
the study (residual disease):Subjects must have previously received an appropriate
first-line treatment regimen.Subjects with suspected residual disease after the
treatment regimen directly preceding study enrollment must have biopsy demonstration
of residual DLBCL. Subjects who have not received high dose chemotherapy/autologous
stem cell transplant (HDT/ASCT) must be ineligible for HDT/ASCT as defined by meeting
any of the following criteria: Age ≥ 70 years ,Diffuse lung capacity for carbon
monoxide (DLCO) < 50% by pulmonary function test (PFT), Left ventricular ejection
fraction (LVEF) < 50% by multiple gated acquisition(MUGA)/echocardiograph (ECHO),
Other organ dysfunction or comorbidities precluding the use of HDT/ASCT on the basis
of unacceptable risk of treatment-related morbidity, Subject refusal of HDT/ASCT.

- Subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on
computed tomography (CT) scan.

Exclusion Criteria:

- Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or
mucosa-associated lymphoid tissue [MALT] lymphoma)

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Known central nervous system (CNS) lymphoma

- Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 3
weeks of the first dose of study drug

- Radio- or toxin-immunoconjugates within 10 weeks of the first dose of study drug

- Major surgery within 2 weeks of first dose of study drug

- Any life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, or put the study
outcomes at undue risk

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification

- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting
gastrointestinal function, or resection of the stomach or small bowel or ulcerative
colitis, symptomatic inflammatory bowel disease, or partial or complete bowel

- Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement

- Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion
support unless there is documented bone marrow involvement

- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0
upper limit of normal (ULN)

- Creatinine > 2.0 x ULN

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the number of patients with a response to study drug

Outcome Description:

Participants will be followed until progression of disease or start of another anti-cancer treatment.

Outcome Time Frame:

24 weeks from first dose

Safety Issue:


Principal Investigator

Darrin Beaupre, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Diffuse Large Cell B-lymphoma
  • PCI-32765
  • Lymphoma, B-Cell
  • Bruton's Tyrosine Kinase
  • Non Hodgkin's Lymphoma
  • Germinal Center B-Cell
  • Activated B-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



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UCLA Medical CenterLos Angeles, California  90095-7059
New York UniversityNew York, New York  10016
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The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
National Cancer InstituteBethesda, Maryland  20892-1922
University of Rochester School of Medicine and DentistryRochester, New York  14642
The Ohio Sate universityColumbus, Ohio  43210
Univerity of WashingtonSeattle, Washington  98109