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.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01325701
First received: February 2, 2011
Last updated: March 7, 2014
Last verified: March 2014

February 2, 2011
March 7, 2014
May 2011
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01325701 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large Cell B-lymphoma
Drug: PCI-32765
  • Experimental: PCI-32765 (Treatment Group 1)
    560 mg/daily
    Intervention: Drug: PCI-32765
  • Experimental: PCI-32765 (Treatment Group 2)
    840 mg/daily
    Intervention: Drug: PCI-32765
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
June 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. ECOG performance status ≤ 2.
  3. Pathologically confirmed de novo DLBCL
  4. Subjects must have available tissue for central pathology review to be eligible. Treatment Group 2: Subjects will be eligible if they have the non-GCB phenotype, as confirmed by Central IHC testing by the Hans method.
  5. Relapsed or refractory disease, defined as either: 1) recurrence of disease after a CR, or 2) PR, 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 who have not received HDT/ASCT must be ineligible for HDT/ASCT
  6. Treatment Group 1: Subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on CT scan. Treatment Group 2: Subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on CT scan.

Exclusion Criteria:

  1. Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).
  2. Primary mediastinal (thymic) large B-cell lymphoma.
  3. Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary.
  4. Certain exclusions on prior therapy
  5. Major surgery within 2 weeks of first dose of study drug.
  6. Any of the following laboratory abnormalities:

    1. ANC < 0.75 x 10^9/L. Treatment Group 2: Eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
    2. Platelet count < 50 x 10^9/L independent of transfusion support. Treatment Group 2 only: Eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
    3. AST or ALT ≥ 3.0 x upper limit of normal (ULN)
    4. Creatinine > 2.0 x ULN
    5. Treatment Group 2 only: Hemoglobin < 8.0 g/dL
    6. Treatment Group 2 only: Total Bilirubin > 1.5 x ULN
  7. Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon)
  8. Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
  9. Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease, hemophilia.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01325701
PCYC-1106-CA, PCI-32765
No
Pharmacyclics
Pharmacyclics
Not Provided
Study Director: Darrin Beaupre, MD Pharmacyclics
Pharmacyclics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP