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A Phase I Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Chemotherapeutic Agents and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic

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Conditions:		Indolent Non-Hodgkin's Lymphoma - Chronic Lymphocytic Leukemia - Mantle Cell Lymphoma
Purpose:		The purpose of this study is to evaluate the safety and clinical activity of CAL-101 in combination with CD20 mAb chemotherapeutic agents, mTOR inhibitors and proteasome inhibitor in patients with hematologic malignancies.
Study Summary:
Criteria:		Inclusion Criteria: - Age ≥ 18 - Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard regimen or progressing within 6 month of the last course of a standard regimen) - WHO performance status of ≤ 2 Exclusion Criteria - Is not a good candidate according to the clinical judgment of the investigator - Patients with atypical immunophenotype with t(11:14) translocation or cyclin D1 over-expression (CLL patients only) - Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to the baseline disease status tests - Had treatment with a short course of corticosteroids for symptom relief within 1-week prior to the baseline tests - Has had an allogeneic hematopoietic stem cell transplant - Has known active central nervous system involvement of the malignancy - Is pregnant or nursing - Has active, serious infection requiring systemic therapy. - Has a positive test for human immunodeficiency virus (HIV) antibodies - Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible. - Has Child-Pugh Class B or C hepatic impairment.
NCT ID:		NCT01088048
Primary Contact:		Study Director Langdon Miller, MD Gilead Sciences
Backup Contact:		N/A
Location Contact:		Springfield, Oregon 97477 United States Jeanne Schaffer Phone: 541-521-8773 Email: Jeanne.Schaffer@USOncology.com Site Status: Recruiting

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