Safety and Efficacy Study of Bruton’s Tyrosine Kinase Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study is ongoing, but not recruiting participants.

First Received on February 2, 2011.  
Last Updated on June 28, 2012  
History of Changes
This Clinical Trial Sponsored By: Pharmacyclics
Information provided by (Responsible Party): Pharmacyclics Identifier: NCT01325701

Purpose for Clinical Trial

The purpose of this study is to evaluate the efficacy of PCI-32765 in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Condition Study Intervention Clinical Trial Phase
Diffuse Large Cell B-lymphoma Drug: PCI-32765 Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics:
Drug Information available for:

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Primary Outcome Measures For Clinical Trial:

  • To measure the number of patients with a response to study drug [ Time Frame: 24 weeks from first dose ] [ Designated as safety issue: No ]
    Participants will be followed until progression of disease or start of another anti-cancer treatment.

Secondary Outcome Measures For Clinical Trial:

  • To measure the number of patients with adverse events as a measure of safety and tolerability. [ Time Frame: For 30 days after the last dose of PCI-32765 ] [ Designated as safety issue: Yes ]
    Participants will be followed until progression of the disease or start of another anticancer treatment.

  • To measure the number of participants pharmacokinetics to assist in determining how the body responses to the study drug. [ Time Frame: Procedure will be performed during the first month of receiving study drug. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)


Assigned Study Interventions

Experimental: PCI-32765 Drug: PCI-32765

560 mg/daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 obstruction
  • 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
  Contacts and Locations

Please refer to this study by its identifier: NCT01325701

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892-1203
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York

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