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A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia


Inclusion Criteria:



1. FOR TREATMENT-NAIVE GROUP ONLY: Men and women ≥ 65 years of age with confirmed
diagnosis of CLL/SLL, who require treatment per NCI or International Working Group
guidelines 15-18

2. FOR RELAPSED/REFRACTORY GROUP ONLY: Men and women ≥ 18 years of age with a confirmed
diagnosis of relapsed/refractory CLL/SLL following previous therapy(ie, failed ≥ 2
previous treatments for CLL/SLL and at least 1 regimen had to have had a purine
analog [eg, fludarabine] for subjects with CLL)

3. FOR HIGH-RISK RELAPSED/ REFRACTORYGROUP ONLY: Men and women ≥ 18 years of age with a
confirmed diagnosis of relapsed/refractory CLL/SLL with suboptimal response to
chemoimmunotherapy, defined as progression of disease within 24 months of initiation
of a regimen containing at least a nucleoside analogue or bendamustine in combination
with a monoclonal antibody or failure to respond to such a regimen. (Note: a minimum
of 2 cycles of chemoimmunotherapy required for eligibility)

4. ECOG performance status of ≤ 2

5. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty

Exclusion Criteria:

1. Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer from which the subject has been
disease free for at least 2 years or which will not limit survival to < 2 years

2. Any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 4 weeks
before first dose of study drug (corticosteroids for disease-related symptoms allowed
but require 1-week washout before study drug administration)

3. Central nervous system (CNS) involvement by lymphoma

4. Major surgery within 4 weeks before first dose of study drug

5. Concomitant use of medicines known to cause QT prolongation or torsades de pointes

6. Significant screening electrocardiogram (ECG) abnormalities including left bundle
branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, and QTc >
470 msec

7. Lactating or pregnant

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety of PCI-32765

Outcome Description:

frequency, severity, and relatedness of adverse events (AEs)

Outcome Time Frame:

30 days after last dose of study drug

Safety Issue:

Yes

Principal Investigator

Danelle James, M.D., M.A.S

Investigator Role:

Study Director

Investigator Affiliation:

Pharmacyclics

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-1102-CA

NCT ID:

NCT01105247

Start Date:

May 2010

Completion Date:

February 2013

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • PCI-32765
  • Lymphoma, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell
  • Bruton's Tyrosine Kinase
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096
Stanford University School of Medicine Stanford, California  94305-5317
The Ohio State University Columbus, Ohio  43210
Northwest Cancer Specialists, P.C. Vancouver, Washington  
Sarah Cannon Nashville, Tennessee  37203
Willamette Valley Cancer Institute and Research Center Springfield, Oregon  97477
Texas Oncology - Tyler Tyler, Texas  75702
University of Vermont and Fletcher Allen Health Care Burlington, Vermont  05405
New York Presbyterian Hosptial Cornell Med Center New York, New York  10065
Yakima Valley Memorial Yakima, Washington  98902