Clearview Cancer Institute - Clinical Trials

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Clinical Trials

Did you know Clearview Cancer Institute has been involved in Clinical Research for over 18 years? Findings from clinical trial research have led to significant advances in cancer prevention and treatment, and Clearview offers numerous clinical trials whereby patients who volunteer for them receive innovative, state-of-the-art cancer care.

Leukemia

A Phase 1b, escalating dose study of AVL-292 , a Bruton’s Tyrosine Kinase (Btk )Inhibitor, as monotherapy in subjects with relapsed and/or refractory B cell NHL, CLL and Waldenstrom’s Macroglobulimemia

Rationale:

Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia are classified as B cell malignancies. Bruton’s tyrosine kinase (Btk) is found mostly in B-lymphocytes, monocytes and mast cells or basophils and is a B-cell receptor (BCR) which is important in cell development. Some B-cell malignancies depend on BCR signaling for survival. Interruption of this signaling may cause cell death. AVL-292 is a select, potent oral compound that inhibits Btk activity resulting in cell death.

Purpose:

Evaluate the safety, tolerability and dose limiting toxicities of AVL-292 when administered orally once daily to patient’s with relapsed or refractory B cell non Hodgkin Lymphoma, chronic lymphocytic leukemia or Waldenstrom’s macroglobulinemia (WM). The trial will also find the recommended dosing of AVL-292 for future studies with this compound.

Eligibility:

• Must have confirmed B-NHL , CLL or WM. • ECOG performance status of > 2. • Must have had at least one treatment regimen. Patients with DLBCL must have failed, refused, be ineligible or not otherwise appropriate, per their physician, for autologous stem cell transplant. • Adequate cardiac function by MUGA or ECHO. • Must have recovered from toxicities from prior treatments. • Adequate labs. • Patient who have received an allogenic bone marrow transplant are not eligible. • Active central nervous system involvement by lymphoma is exclusionary. • Patients with certain blood conditions are not eligible. • Use of corticosteroids greater than 20mg/d is exclusionary. • Cannot have active infection. • Certain heart conditions are exclusionary. • History of another active cancer less than 2 years prior to study dosing is exclusionary. • Cannot have had a major surgical procedure within 28 days of study drug administration. • Certain eye conditions are exclusionary. • Patients that are Hepatitis B or Hepatitis C or HIV positive are excluded.

Treatment:

AVL-292 125 mg by mouth daily. This dose will escalate with each cohort.

Contact:

Kathy Cutter, RN, BSN; 256-705-4248

Current Clinical Trials:

Emily Pauli, Pharm.D.Director of Research

If you are interested in more information on clinical trials at Clearview, please feel free to contact us (256) 705-4224. More information regarding clinical trials can be found at: www.ClinicalTrials.gov

Entering a Clinical Trial: Is it right for you? Download the PDF.