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.

Lymphoma

An open label phase I/II study of Ublituximab in combination with Lenalidomide (Revlimid) in patients with B-cell lymphoid malignancies ( NHL, CLL/SLL) who have relapsed or are refractory after CD20 directed antibody therapy

Rationale:

Ublituximab is a monoclonal antibody that specifically binds to the trans- membrane antigen CD20. This binding induces an immune response that causes B-cell death. In a previous study, Ublituximab was shown to be safe and active treatment for patients with Chronic Lymphocytic Leukemia (CLL). Lenalidomide is an immunomodulatory agent with promising clinical activity in NHL and CLL that has displayed potential for synergistic activity to enhance the antibody-dependent cellular cytotoxicity effects of the antibody thereby inducing a more potent immune response.

Purpose:

The purpose of this study is to explore the safety and efficacy of ublituximab in combination with lenalidomide in patients with B-cell lymphoid malignancies.

Eligibility:

  • Histologically confirmed relapsed or refractory B-cell NHL, CLL/SLL with measurable disease defined by Cheson criteria.
  • Patients must have received at least one prior line of treatment with Rituxan or a Rituxan-containing regimen.
  • Prior autologous or allogenic stem cell transplant within 6 months of study entry are excluded.
  • Adequate labs
  • No history of Hepatitis B or C or HIV.
  • Cannot have received a live vaccine within 2 months of study entry.
  • All patients must register through the Revassist program and be willing to comply with their requirements.
  • No history of deep venous thrombosis (DVT) or pulmonary embolism (PE) within 6 months of study entry.
  • Uncontrolled inter-concurrent illnesses are excluded.

    • Treatment:

  • Ublituximab Cycles 1 and 2 days, 1, 8, 15 then Cycle 4 day 1 and Cycle 6 day1
  • Revlimid – days 9-28 during cycle 1 then daily thereafter through cycle 6

    • Contact:

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




    A Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

    Rationale:

    Certain malignant B cells rely on B-cell receptor (BCR)-mediated survival signals. Spleen tyrosine kinase (Syk) initiates and amplifies the BCR signal. Enhanced BCR-signaling through Syk occurs in follicular lymphoma cells compared with nonmalignant B-cells. As activation of Syk is a principal cause of DLBCL in a segment of patients with B-cell Receptor Activation (BCA+). The active metabolite in fostamatinib inhibits Syk and eliminates tumor cells addicted to B-Cell Receptor (BCR) pathway. Therefore, a Syk inhibitor, fostamatinib, represents a novel, rational therapeutic target for a subset of BCR- dependent lymphomas.

    Purpose:

    The aim is to evaluate the proven effective biological dose and tolerability of oral fostamatinib at 200 mg twice per day in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

    Eligibility:

    • Patients must have relapsed or refractory diffuse large B-cell lymphoma (DLBCL )
    • Patients must have previously received R-CHOP (or equivalent) chemo-immunotherapy and high-dose chemotherapy with stem-cell rescue, or are ineligible for high-dose chemotherapy with stem-cell rescue.
    • Must have measurable disease as defined by Cheson et al 2007 criteria
    • All patients must agree to provide the following: (1) previously obtained archival tumor biopsy, and (2) one fresh pre-treatment excisional tumor biopsy, OR provision of a previous excisional biopsy obtained following last relapse with fresh frozen tissue available.
    • May not have active evidence of Hepatitis B or C, HIV or TB.
    • Able to swallow and retain oral medication
    • Must have World Health Organization (WHO) performance status 0 to 1
    • Must have adequate bone marrow reserve and organ function as evidenced by specified laboratory values

    Treatment:

    • Fostamatinib at a dose of 200 mg orally twice per day.

    Contact:

    Leslie Smoot, RN 256-705-4246




    An open label phase I/II study of the efficacy and safety of Ublituximab in patients with B-cell Non Hodgkins Lymphoma who have relapsed or are refractory after CD20 directed antibody therapy

    Rationale:

    Ublituximab is a monoclonal antibody that specifically binds to the trans-membrane antigen CD20. This binding causes B-cell death. In a previous study, Ublituximab was shown to be safe and active treatment for patients with Chronic Lymphocytic Leukemia (CLL). The purpose of this study is to explore the safety and efficacy of Ublituximab in patients with B-cell lymphoma.

    Purpose:

    The objective is to determine a recommended dose and dose limiting toxicities of treatment with Ublituximab in patients with relapsed/refractory B-cell NHL. In the Phase II portion of the trial, the objective will be to determine the overall response rate defined as complete response and partial response.

    Eligibility:

    Histologically confirmed relapsed or refractory B-cell NHL. Measurable disease by CT scan and Bone Marrow Biopsy. Patients must have received at least one prior line of treatment with Rituxan or Rituxan containing regimen. Patients must be ineligible for combination therapy or stem cell transplant. No history of Hepatitis B or C or HIV.

    Treatment:

    Days 1, 8, 15, 22 then maintenance cycles every 28 days for Cycles 3, 4, 5, 6 and 9 using a dose escalating schema, beginning with 450 mg/dose.

    Contact:

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




    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




    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:

    At this time, the study is only enrolling Mantle Cell Lymphoma patients.
    Documented histologically or cytologically confirmed select types of B-cell indolent NHL
    • 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:

    CAL-101 150 mg twice daily plus treatment with Bortezomib administered at a dose of 1.3 mg/m2 as a subcutaneous injection once weekly for 3 weeks (Days 1, 8, and 15) followed by a 13 day rest period. For patients with MCL only.

    Contact:

    Kathy Cutter, RN, BSN 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.