The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on chronic lymphocytic leukemia. These studies are investigating multiple combination chemotherapies; regimens for relapsed and/or refractory disease; the role of inhibitors; T-cell infusion; integrative methods of treatment; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I
Study Title: A Dose Escalation Study of Ibrutinib With Lenalidomide for Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the side effects and best dose of lenalidomide when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after a period of improvement or does not respond to treatment
Primary Outcome Measures: Maximum tolerated dose of lenalidomide when combined with ibrutinib defined as the highest dose in which up to one in six patients has dose-limiting toxicity [time frame: 28 days]
Principal Investigator: Daniel A. Pollyea, MD, University of Colorado Cancer Center–Anschutz Cancer Pavilion; (720) 848-8084
ClinicalTrials.gov Identifier: NCT01886859
Phase I/II
Study Title: Obinutuzumab, Ibrutinib, and Venetoclax for Relapsed and Previously Untreated Chronic Lymphocytic Leukemia
Study Type: Phase I/II/interventional/single-group assignment
Study Sponsor and Collaborators: The Ohio State University Comprehensive Cancer Center
Purpose: To study the best dose and safety of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib and to see how well they work in treating patients with chronic lymphocytic leukemia that is relapsed and/or refractory or is previously untreated
Primary Outcome Measures: Maximum tolerated dose of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib (phase Ib) [time frame: 28 days (course 3)]; minimal residual disease–complete response defined by the IWCLL 2008 criteria (phase II) [time frame: up to 8 weeks posttreatment]
Principal Investigator: Jeffrey Jones, MD, MPH, The Ohio State University Comprehensive Cancer Center; contact 1(800) 293-5066, jamesline@osumc.edu
ClinicalTrials.gov Identifier: NCT02427451
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Study Title: A Phase I/II Study of Pyrimethamine, a STAT3 Inhibitor, for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type: Phase I/II/interventional/single-group assignment
Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, Lymphoma Research Foundation
Purpose: To establish the highest dose of pyrimethamine that can be given safely to patients with chronic lymphocytic leukemia without severe or unmanageable side effects. This dose will then be used for a larger phase II study to assess the efficacy of pyrimethamine for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma.
Primary Outcome Measures: Phase I: To determine the maximum tolerated dose and recommended phase II dose of pyrimethamine in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma [time frame: 1 year]; Phase II: To determine the overall response rate of pyrimethamine in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma [time frame: 2 years]
Principal Investigator: Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute; (617) 632-6692
ClinicalTrials.gov Identifier: NCT01066663
Phase II
Study Title: Trial of Immune Reconstitution With Activated T Cells Following Lymphodepleting Chemotherapy in Patients With Chronic Lymphocytic Leukemia
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: MD Anderson Cancer Center
Purpose: To learn whether an activated T-cell infusion, when given with or without lenalidomide, can help to restore the immune systems of patients with chronic lymphocytic leukemia when given after chemotherapy (rituximab and fludarabine with cyclophosphamide or bendamustine)
Primary Outcome Measures: Success of autologous T cells for immune restoration in participants with chronic lymphocytic leukemia [time frame: 90 days]; feasibility of autologous T cells for immune restoration in participants with chronic lymphocytic leukemia [time frame: 90 days after T-cell infusion]
Principal Investigator: Chitra M. Hosing, MD; (713) 792-8750
ClinicalTrials.gov Identifier: NCT02530515
Study Title: A Phase II Study of Curcumin and Vitamin D in Previously Untreated Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute
Purpose: To study the efficacy and tolerability of curcumin and cholecalciferol combination in treating patients with previously untreated stage 0–II chronic lymphocytic leukemia or small lymphocytic lymphoma
Primary Outcome Measures: Overall response rate (biologic response rate + complete response + partial response) based on NCI-WG (for chronic lymphocytic leukemia) and Cheson criteria (for small lymphocytic lymphoma ) [time frame: until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years]
Principal Investigator: Paolo Caimi, MD, Case Comprehensive Cancer Center; (216) 844-0362, paolo.caimi@uhhospitals.org
ClinicalTrials.gov Identifier: NCT02100423
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Study Title: A Phase II Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia and Untreated Chronic Lymphocytic Leukemia Patients With Genomic Deletion 11q
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: University of Michigan Cancer Center
Purpose: Given the investigators preliminary published data on insulin and mTOR inhibition, to study whether metformin is a viable candidate for treatment in patients with chronic lymphocytic leukemia
Primary Outcome Measures: Time to treatment failure [time frame: every 3 months]
Principal Investigator: Sami Malek, MD, University of Michigan Cancer Center; (734) 936-5310, smalek@med.umich.edu
ClinicalTrials.gov Identifier: NCT01750567 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
