Clearview Cancer Center

Quick Links:

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.

Non-Hodgkins Lymphoma

A Phase II study to assess the efficacy and safety of CAL -101 in patients with Indolent B-Cell Non- Hodgkin Lymphoma refractory to Rituxan and Alkylating agents

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:

The purpose of the study is to continue to evaluate the efficacy and safety of CAL -101 in the refractory or relapsed NHL setting as demonstrated in previous Phase I trials. Given the seriousness of iNHL and the aggregate potential benefits considered in the context of potential risks, further development of CAL-101 in the phase II clinical trial is justified.

Eligibility:

  • Must be at least 19 years of age with a performance status of 0-2
  • Histologically confirmed diagnosis of B-cell iNHL with histological subtypes limited to: Follicular, Small lymphocytic lymphoma, or Marginal zone lymphoma
  • Measureable disease defined as at least one lymph node greater than 2cm in one dimension
  • Prior treatment with >2 chemotherapy or immunotherapy based regimens for NHL that is refractory to Rituxan and to Alkylating agents.
  • Central nervous system or leptomeningeal lymphoma is excluded
  • Patients with a history of other malignancies are excluded
  • Patients that have undergone prior allogenic bone marrow progenitor or solid organ transplant are excluded.
  • Patients receiving immunosuppressive therapy including systemic corticosteriods are excluded.
  • Any clinically significant medical condition, deemed by the physician to affect the safety of the patient, will exclude the patient.

    • Treatment:

    CAL-101 150 mg by mouth twice a day

    Contact:

    Kathy Cutter, RN, BSN 256-705-4248




    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




    Current Clinical Trials:

    [Emily Pauli, Pharm.D.]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.