Clinical Trials

Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia

Location:

Jacksonville,  FL

Trial status:

Open for Enrollment

Why is this study being done?

Bruton's tyrosine kinase (Btk) is non-receptor tyrosine kinase with restricted cellular expression largely limited to B-lymphocytes, monocytes, and mast cells or basophils. Btk is a critical component of the B cell receptor (BCR) signaling network and is crucial for B cell development. Investigation has revealed that some B cell lymphomas and CLL depend on BCR signaling, suggesting that interruption of such signaling could be a promising therapeutic opportunity in B-NHL, CLL and WM.

Who is eligible to participate?

Inclusion Criteria:

- Women and men ≥18 years of age

- Body weight ≥50 kg.

- Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization [WHO] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop)

- Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.

- Eastern Cooperative Oncology Group performance status of ≤ 2 and a life expectancy of at least 3 months.

- Ability to swallow oral capsules without difficulty

- Has recovered from adverse toxic effects of prior therapies

- Meet the following clinical laboratory requirements:

- Creatinine ≤ 1.5 × upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 x ULN

- AST and ALT ≤ 3 × ULN

- Platelet count ≥ 50,000/µL (non-hodgkin & Waldenstrom's)

- Platelet count ≥ 30,000/µL (chronic lymphocytic leukemia)

- Absolute Neutrophil count ≥ 1000/µL

Exclusion Criteria:

- Prior allogeneic bone marrow transplant

- Autologous stem cell transplant within 3 months of screening

- Active central nervous system involvement

- Subjects with autoimmune hemolytic anemia or immune thrombocytopenia

- Prior treatment with a Btk inhibitor

- Active uncontrolled infection

- History of malabsorption

- Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.

- History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months

- History of another currently active cancer

- History of major surgery within 4 weeks or minor surgery within 1 week

- Other medical or psychiatric illness or organ dysfunction

- HIV positive

- Positive for Hepatitis B surface antigen or Hepatitis C-virus

Last updated: 09/07/2012

NCT ID:

NCT01351935