Clinical Trials Actively Recruiting Patients With Hodgkin Lymphoma and Non-Hodgkin Lymphoma

The information contained in this Clinical Trials Resource Guide includes clinical studies actively recruiting people with Hodgkin lymphoma, non-Hodgkin lymphoma (NHL), including AIDS-related NHL, as well as studies that are also recruiting patients with multiple myeloma and mantle cell lymphoma. The studies include pilot, phase I, II, and interventional trials evaluating gene therapy; therapies in the relapsed/refractory setting; single-agent and combination chemotherapies; and a geriatric assessment to predict chemotherapy or chemoimmunotherapy toxicity in older patients with NHL. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

PILOT

Study Type: Pilot/interventional/single-group assignment

Study Title: Safety and Feasibility of Gene Transfer After Frontline Chemotherapy for Non-Hodgkin Lymphoma in AIDS Patients Using Peripheral Blood Stem/Progenitor Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs

Study Sponsor and Collaborators: City of Hope Medical Center; National Cancer Institute

Purpose: To study gene therapy after front-line chemotherapy in treating patients with AIDS-related non-Hodgkin lymphoma. Placing genes for anti–human immunodeficiency virus (HIV) RNA into stem/progenitor cells may make the body build an immune response to AIDS. Giving the chemotherapy drug busulfan (Busulfex) before gene therapy can help gene-modified cells engraft and work better.

Ages Eligible for Study: 18 to 65 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Procedure related toxicity as determined by adverse events grading scale using the NCI Common Terminology Criteria for Adverse Events version 4.0 (time frame: up to 15 years)

Principal Investigator: Amrita Y. Krishnan, MD, City of Hope; 626-256-4673, akrishnan@coh.org.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01961063

Study Title: A Pilot Study of Single-Agent Ibrutinib in Relapsed or Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma

Study Sponsor and Collaborators: University of Washington; National Cancer Institute

Purpose: To study ibrutinib (Imbruvica) in the treatment of patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall response rate, combined complete response, plus partial response (time frame: up to 5 years)

Principal Investigator: Ajay K. Gopal, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-288-2037

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02207062

PHASE I

Study Type: Phase I/interventional/single-group assignment

Study Title: Phase I Study of the Aurora Kinase Inhibitor MLN8237 in Combination With the Histone Deacetylase Inhibitor Vorinostat in Lymphoid Malignancies

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and the best dose of alisertib (MLN8237) when given together with vorinostat (Zolinza) in treating patients with relapsed or recurrent Hodgkin lymphoma, B-cell non-Hodgkin lymphoma, or peripheral T-cell lymphoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum-tolerated dose of alisertib defined as the highest dose tested in which less than 33% of patients experienced dose-limiting toxicity graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (time frame: 21 days)

Principal Investigator: Tanya Siddiqi, MD, Beckman Research Institute; 626-256-4673, tanyasiddiqi@coh.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01567709

Study Title: A Phase I Study of MLN8237 in Combination With Bortezomib and Rituximab in Relapsed and Refractory Mantle Cell and Low Grade Non-Hodgkin Lymphoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of alisertib (MLN8237) and bortezomib (Velcade) when given together with rituximab (Rituxan) in treating patients with mantle cell lymphoma or B-cell low-grade non-Hodgkin lymphoma that has relapsed or is refractory

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Recommended phase II dose of alisertib when combined with bortezomib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose-limiting toxicity (time frame: 21 days)

Principal Investigator: Catherine S. Diefenbach, MD, Montefiore Medical Center; 212-731-5670, catherine.diefenbach@nyumc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01695941

Study Title: Phase I Study of the Administration of EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma (CAR CD 30)

Study Sponsor and Collaborators: Baylor College of Medicine; Center for Cell and Gene Therapy, Baylor College of Medicine; Texas Children’s Hospital; The Methodist Hospital System

Purpose: Researchers have found that they can put a new gene into T cells that will make them recognize cancer cells and kill them. This study will investigate whether researchers can attach a new gene to T cells that will help them do a better job at recognizing and killing lymphoma cells.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T lymphocytes (time frame: 6 weeks)

Principal Investigator: Helen E. Heslop, MD, Baylor College of Medicine/Center for Cell and Gene Therapy; 832-824-4662, heheslop@txch.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01192464

Study Title: Phase I Dose-Escalation Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Classic Hodgkin Lymphoma

Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University; National Cancer Institute

Purpose: To test the side effects and best dose of CPI-613 when given together with bendamustine hydrochloride (Treanda) in patients with relapsed or refractory T-cell non-Hodgkin lymphoma or Hodgkin lymphoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of 6,8-bis (benzylthio) octanoic acid when used in combination with bendamustine hydrochloride, defined as the dose level immediately below the dose level that induced a dose-limiting toxicity in patients (time frame: up to 28 days)

Principal Investigator: Zanetta S. Lamar, MD, Comprehensive Cancer Center of Wake Forest University; 336-716-7448, ziamar@wakehealth.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02168140

Study Title: Phase I Study of Cellular Immunotherapy Using Central Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin ­Lymphoma

Study Sponsor and Collaborators: City of Hope Medical Center; National Cancer Institute

Purpose: To investigate the highest possible dose of central memory enriched T cells that can be given following standard stem cell transplant before unmanageable side effects are seen in patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of dose-limiting toxicities defined as any grade 3 or higher toxicity requiring the use of steroids, any grade 3 or greater autoimmune toxicity, or failure for a research participant with documented T-cell persistence to engraft by day 21 post–hematopoietic stem cell transplant (time frame: up to 28 days)

Principal Investigator: Leslie L. Popplewell, MD, City of Hope Medical Center; 800-826-4673

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02051257

Study Title: Phase I and Pharmacokinetic Study of Ibrutinib in HIV-Infected Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of ibrutinib (Imbruvica) in the treatment of B-cell non-Hodgkin lymphoma that has recurred or does not respond to treatment in patients with human immunodeficiency virus (HIV) infection

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Incidence of toxicities assessed using NCI Common Terminology Criteria for Adverse Events version 4.0 (time frame: 28 days)

Principal Investigator: Yvette L. Kasamon, MD, AIDS Associated Malignancies Clinical Trials Consortium; 410-955-8839, ykasamon@jhmi.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02109224

PHASE II

Study Type: Phase II/Interventional/Single Group Assignment

Study Title: A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T-Cell Non-Hodgkin Lymphoma

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; University of Washington; Weill Medical College of Cornell University

Purpose: To test the benefit of romidepsin (Istodax) in patients with T-cell non-Hodgkin lymphoma who have undergone autologous transplantation

Ages Eligible for Study: 16 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival for patients with high-risk histologies (time frame: 2 years)

Principal Investigator: Steven Horowitz, MD, Memorial Sloan Kettering Cancer Center; 212-639-3045

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01908777

Study Title: A Phase II Trial of Prostaglandin E2 Inhibition, Using Meloxicam, Plus Filgrastim for Mobilization of Autologous Peripheral Blood Stem Cells in Patients With Multiple Myeloma and Non-Hodgkin’s Lymphoma

Study Sponsor and Collaborators: Indiana University; National Cancer Institute

Purpose: This trial is an open-label Simon optimal two-stage phase II trial of fixed doses of oral meloxicam and subcutaneous filgrastim (Neupogen) to assess the safety and efficacy in mobilizing autologous peripheral blood stem cells from patients with multiple myeloma and non-Hodgkin lymphoma who are planning to undergo high-dose chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of patients who mobilize and collect at least half of the total target CD34-positive cell dose in the first apheresis (time frame: 4 years)

Principal Investigator: Sherif Farag, MBBS, PhD, Indiana University; 317-944-1781, ssfarag@iupui.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02078102

Study Title: Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin’s and Non-Hodgkin’s Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation—A Multicenter Phase II Study

Study Sponsor and Collaborators: West Virginia University

Purpose: To investigate reduced toxicity conditioning with once daily intravenous busulfan (Busulfex) and fludarabine in patients with relapsed/refractory Hodgkin and non-Hodgkin lymphoma undergoing allogeneic hematopoietic cell transplantation

Ages Eligible for Study: 18 to 70 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To assess 1 year progression-free survival in patients with chemotherapy-refractory Hodgkin and non-Hodgkin lymphoma undergoing reduced-toxicity conditioning with once daily intravenous busulfan and fludarabine (time frame: 1 year)

Principal Investigator: Abraham Kanate, MD, West Virginia University. Contact: Crystal Stevens, MT; 304-598-4512, stevensc@wvuhealthcare.com

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01203020

INTERVENTIONAL

Study Type: Interventional/single-group assignment

Study Title: Personalized Monitoring of Intravenous Busulfan Dosing for Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation

Study Sponsor and Collaborators: Case Comprehensive Cancer Center; National Cancer Institute

Purpose: To investigate personalized dose monitoring of busulfan (Busulfex) and combination chemotherapy in treating patients with Hodgkin or non-Hodgkin lymphoma undergoing stem cell transplant

Ages Eligible for Study: 2 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility of performing real-time therapeutic dose monitoring, determined by the proportion of enrolled patients who are able to have an area under the curve for busulfan calculated (time frame: up to day 6)

Principal Investigator: Brian T. Hill, MD, Case Comprehensive Cancer Center; 216-445-9451, hillb2@ccf.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01959477

Study Title: Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To evaluate the ability of a largely self-administered geriatric assessment to predict toxicity in patients 60 years and older with non-Hodgkin lymphoma receiving chemotherapy or chemoimmunotherapy

Ages Eligible for Study: 60 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Toxicity assessment (time frame: 3 years)

Principal Investigator: Paul Hamlin, MD, Memorial Sloan Kettering Cancer Center; 212-639-6143

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01829958 ■