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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


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

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To measure the number of participants with prolonged hematologic toxicity

Outcome Time Frame:

8 weeks from first dose

Safety Issue:

Yes

Principal Investigator

Thorsten Graef, MD

Investigator Role:

Study Director

Investigator Affiliation:

Pharmacyclics

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-1108-CA

NCT ID:

NCT01292135

Start Date:

February 2011

Completion Date:

May 2013

Related Keywords:

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

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021
University of RochesterRochester, New York  14642
MD AndersonHouston, Texas  77230
Sarah Cannon Research InstituteNashville, Tennessee  37203
Dana Farber Cancer CenterBoston, Massachusetts  02115
CLL Research and Treatment ProgramNew Hyde Park, New York  11042