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An Open-label, Phase 1b/2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Prolymphocytic Leukemia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Well-Differentiated Lymphocytic Lymphoma, Prolymphocyctic Leukemia, Richter's Transformation

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Trial Information

An Open-label, Phase 1b/2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Prolymphocytic Leukemia


Inclusion Criteria:



- Subjects with histologically confirmed chronic lymphocytic leukemia (CLL), small
lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL) as defined by WHO
classification of hematopoietic neoplasms, or Richter's transformation arising out of
CLL/SLL and satisfying ≥ 1 of the following conditions:

- 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 degree 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

- Need for cytoreduction prior to stem cell transplant

- Subjects must have failed ≥ 2 prior therapies for CLL including a nucleoside analog
or ≥ 2 prior therapies not including nucleoside analog if there is a contraindication
to such therapy

•> 10% expression of CD20 on tumor cells

- ECOG performance status ≤ 2

- Life expectancy ≥ 12 weeks

- Subjects must have organ and marrow function as defined below:

Absolute neutrophil count (ANC) ≥ 1000/µL in the absence of bone marrow involvement
Platelets ≥ 30,000/μL Total bilirubin ≤ 1.5 x institutional upper limit of normal unless
due to Gilbert's disease AST(SGOT) ≤ 2.5 x institutional upper limit of normal unless due
to infiltration of the liver Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min

- No history of prior anaphylactic reaction to rituximab

- No history of prior exposure to ofatumumab

- Age ≥ 18 years

- Body weight ≥ 40 kg

Exclusion Criteria:

- A 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

- Significant cardiovascular disease

- Any condition which could interfere with the absorption or metabolism of PCI-32765
including unable to swallow capsules, 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

- Known history of Human Immunodeficiency Virus (HIV) or active infection with
Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active
systemic infection

- Any anticancer immunotherapy, chemotherapy, radiotherapy, or experimental therapy
within 4 weeks before first dose of study drug. Corticosteroids for disease-related
symptoms are allowed provided 1 week washout occurs.

- Active central nervous system (CNS) involvement by lymphoma

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

- Lactating or pregnant

- Known moderate to severe chronic obstructive pulmonary disease (COPD)

- History of 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

- History of Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer
therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response and safety of PCI-32765

Outcome Description:

Response rate as defined by recent guidelines in Chronic Lymphocytic Leukemia

Outcome Time Frame:

At the end of cycles 1 and 3

Safety Issue:

Yes

Principal Investigator

Samantha Jaglowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-1109-CA

NCT ID:

NCT01217749

Start Date:

December 2010

Completion Date:

September 2013

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Diffuse Well-differentiated Lymphocytic Lymphoma
  • Prolymphocyctic Leukemia
  • Richter's Transformation
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Lymphoma

Name

Location

The Ohio State UniversityColumbus, Ohio  43210