Clearview Cancer Center

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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.

Early Phase

A Phase I Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination with Bendamustine and Rituxan in Patients with Relapsed or Refractory Indolent B-cell Non Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia

Rationale:

CAL-101 is a small molecule that inhibits a protein P13K that is expressed in Non Hodgkin’s Lymphoma and Leukemia. Through a series of signaling pathways, CAL-101 inhibits the production of this protein (P13K) which effects cell survival, proliferation, growth and metabolism.

Purpose:

This Phase I study will be the first time that CAL-101 is administered in combination with chemotherapy in patients with relapsed or refractory indolent B-cell Non Hodgkin’s Lymphoma or CLL. This study will establish initial safety and clinical activity of CAL-101 in combination with Rituximab and Bendamustine

Eligibility:

• Documented histologically or cytologically confirmed select types of B-cell indolent NHL or CLL • Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard treatment or progressing within 6 months of the last course of standard treatment.) • Must have measurable disease • Patient’s with atypical immunophenotype with t(11:14) translocation or cyclin D1 over-expression are excluded • Patient’s that have been treated within 4 weeks are excluded • Patient’s that have had an allogeneic hematopoietic stem cell transplant are ineligible • Patient’s with central nervous system involvement are excluded • Must have adequate lab values • Patient’s who test positive for HIV, hepatitis B or C are excluded • Patient’s on certain medications are excluded

Treatment:

Patients will be enrolled in one of the three arms of the study. Arm 1 – CAL-101 and Bendamustine Arm 2 – CAL- 101 and Rituximab Arm 3 – CAL-101, Bendamustine and Rituximab

Contact:

Kathy Cutter, RN, BSN phone: 256-705-4248




CCI has several Early Phase trials available for our patients. Your physician will consult with you if they feel you could benefit from trial participation

Contact:

Emily K Pauli, Pharm. D., Director, Investigational Research @ 256-327-5899




Current Clinical Trials:

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