Ongoing Clinical Trials Actively Recruiting Patients With Hodgkin Lymphomas

The information in this Clinical Trials Resource Guide includes details of actively recruiting clinical studies of patients with Hodgkin lymphomas, including patients with human immunodeficiency virus–associated and Epstein-Barr virus–positive Hodgkin lymphoma. Two of the studies are also recruiting patients with mature T-cell lymphoma, multiple myeloma, and diffuse large B-cell lymphoma. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov. The studies are all phase I and II clinical trials.

Study Type: Phase II/interventional/single group assignment

Study Title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma.

Study Sponsor and Collaborators: Cancer and Leukemia Group B; National Cancer Institute

Purpose: Diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors plan the best treatment for their patients. This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma.

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival at 36 months from enrollment (time frame: up to 8 weeks)

Principal Investigator: Ann S. LaCasce, MD, Dana-Farber Cancer Institute; 617-632-5959

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01118026

Study Title: A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: This pilot phase I/II trial is studying the side effects and the best dose of brentuximab vedotin and combination chemotherapy in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Giving brentuximab vedotin together with combination chemotherapy may be more effective in killing more cancer cells.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximal tolerated doses of brentuximab vedotin when combined with AVD (doxorubicin hydrochloride, vinblastine, and dacarbazine) chemotherapy regimen in HIV patients with advanced stage Hodgkin lymphoma (time frame: 28 days); progression-free survival for patients using brentuximab vedotin plus AVD regimen with HIV-associated advanced stage Hodgkin lymphoma (time frame: 2 years)

Principal Investigator: Paul G. Rubinstein, MD, AIDS Associated Malignancies Clinical Trials Consortium; 312-864-7277; prubinstein@cookcountyhhs.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01771107

Study Title: A Phase II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematapoietic Stem Cell Transplantation

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

Purpose: To study how well giving brentuximab vedotin before autologous stem cell transplant works in treating patients with Hodgkin lymphoma.

Ages Eligible for Study: 11 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall response rate of salvage brentuximab vedotin treatment for Hodgkin lymphoma before autologous hematopoietic stem cell transplantation (time frame: 21 days after completion of last course of study treatment)

Principal Investigator: Robert W. Chen, MD, City of Hope Medical Center; 800-826-4673; rchen@coh.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01393717

Study Title: A Multicenter Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation Followed by Adoptive Cellular Immunotherapy With Donor Derived Latent Membrane Protein (LMP) Specific-CTLs in Patients With Epstein-Bar Virus (EBV) Positive Refractory or Recurrent Hodgkin Lymphoma

Study Sponsor and Collaborators: New York Medical College; Children’s Research Institute, Baylor College of Medicine, MD Anderson Cancer Center, Beckman Research Institute, Johns Hopkins University, Ohio State University, University of Utah, and the University of Michigan

Purpose: To utilize reduced intensity conditioning and allogeneic stem cell transplantation (AlloSCT) from EBV-positive HLA-matched sibling or unrelated adult donor combined with post-AlloSCT allogeneic donor-derived latent membrane protein (LMP)-specific cytotoxic T-lymphocyte infusions in EBV-positive patients with poor-risk Hodgkin lymphoma. One of three reduced intensity conditioning regimens predetermined at each institutional center of the Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or matched unrelated adult donor allogeneic transplant followed by donor LMP-specific cytotoxic T-lymphocyte infusion for three doses post-AlloSCT. The investigators hypothesize that the addition of donor-derived LMP-specific cytotoxic T-lymphocytes will be safe and feasible.

Ages Eligible for Study: Up to 45 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Safety and toxicity: The number of serious adverse events associated with administering allogeneic HLA-matched donor derived LMP-specific CTSs in CAYA with EBV-associated refractory/relapsed Hodgkin lymphoma following reduced intensity and allogeneic stem cell transplant (time frame: 1 year)

Principal Investigator: Mitchell S. Cairo, MD, New York Medical College; 914-594-3650; mitchell_cairo@nymc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01636388

Study Title: Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To test whether giving alemtuzumab (Campath) in combination with continuous infusion EPOCH-R (etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone, and rituximab) chemotherapy will improve the outcome of lymphoma treatment. This protocol is specifically for people with diffuse large B-cell or Hodgkin lymphoma who have not responded to standard treatments.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To assess response, progression-free survival, and overall survival in relapsed/refractory DLBCL and Hodgkin lymphoma (time frame: 5 years)

Principal Investigator: Wyndham H. Wilson, MD, National Cancer Institute; 301-435-2415; wilsonw@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01030900 ■