Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Information provided by (Responsible Party):
Pharmacyclics Identifier:
First received: February 2, 2011
Last updated: June 13, 2013
Last verified: June 2013

February 2, 2011
June 13, 2013
February 2011
November 2012   (final data collection date for primary outcome measure)
To measure the number of participants with prolonged hematologic toxicity [ Time Frame: 8 weeks from first dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01292135 on Archive Site
  • To measure the number of participants 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 ]
  • To measure the number of patients who respond to treatment by measuring the increase or decrease of disease in the lymph nodes and/or blood test results [ Time Frame: Patients may remain on study until the last subject enrolled completes a maximum of 12 cycles of PCI-32765. Any subjects still receiving PCI-32765 at that time may enroll in a long-term follow-up study to continue to receive PCI-32765 capsules ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)
A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).

This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • B-cell Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Drug: PCI-32765
420 mg daily
  • Experimental: PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)
    Intervention: Drug: PCI-32765
  • Experimental: PCI-32765 plus bendamustine/rituximab (BR)
    Intervention: Drug: PCI-32765
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:
  • Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
  • Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement
  • Presence of unintentional weight loss > 10% over the preceding 6 months
  • NCI CTCAE Grade 2 or 3 fatigue
  • Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection
  • Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
  • 1 to 3 prior treatment regimens for CLL/SLL
  • ECOG performance status of ≤ 1

    ≥ 18 years of age

  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Exclusion Criteria:

  • Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
  • Concomitant use of medicines known to cause QT prolongation or torsades de pointes
  • Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
  • Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) < 1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
PCYC-1108-CA, PCI-32765
Not Provided
Study Director: Thorsten Graef, MD Pharmacyclics
June 2013

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