Select Clinical Trials Currently Enrolling Patients with Lymphoma

March 2018, Vol 8, No 3 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with different types of lymphoma for inclusion in investigations of new therapies as well as new regimens of existing treatments for patients with lymphoma. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncologists and other oncology practice providers direct eligible patients to an appropriate clinical trial.

1 Blinatumomab for Relapsed or Refractory Indolent NHL

This single-group assignment, open-label, phase 2 clinical trial is investigating the safety and efficacy of blinatumomab (Blincyto) in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). Patients aged ≥18 years with histologically confirmed B-cell NHL that was refractory to or has relapsed after initial therapy may be eligible for enrollment if other criteria are met. All patients will receive blinatumomab therapy.

The primary outcome measure is the overall response rate (ORR) at 6 months. The secondary outcome measures are overall survival (OS), progression-free survival (PFS), time to response, duration of response, and the drug discontinuation rate. This study plans to enroll 28 patients at the Massachusetts General Hospital, Boston. For more information, call Jeffrey Barnes, MD, PhD, at 617-724-4000. The NLM Identifier is NCT02811679.

2 Lenalidomide plus Obinutuzumab for Relapsed Indolent NHL

The purpose of this nonrandomized, parallel-assignment, open-label, phase 1/2 clinical trial is to determine the highest tolerable dose of lenalidomide (Revlimid) plus obinutuzumab (Gazyva) that can be given to patients with relapsed, indolent NHL, and how well the drugs work as a combination therapy. Patients aged ≥18 years with small lymphocytic lymphoma, follicular lymphoma, or marginal-zone lymphoma that was refractory to or relapsed after ≥1 previous treatments for indolent lymphoma may be eligible for enrollment if other criteria are met. Participants will receive lenalidomide plus obinutuzumab.

The primary outcome measure is the maximum tolerated dose of lenalidomide plus obinutuzumab. The secondary outcome measure is objective response, defined as complete response plus partial response. This study expects to enroll 72 patients at the University of Texas M.D. Anderson Cancer Center, Houston. For more information, call Nathan Fowler, MD, at 713-792-2860. The NLM Identifier is NCT01995669.

3 Safety and Efficacy of Ibrutinib plus Rituximab for Mantle-Cell Lymphoma

This parallel-assignment, open-label, nonrandomized, phase 2 clinical trial is evaluating the efficacy and safety of combining ibrutinib (Im­bruvica) with rituximab (Rituxan) in patients with relapsed or refractory mantle-cell lymphoma, or those who are elderly and are newly diagnosed with mantle-cell lymphoma. Patients aged ≥18 years with relapsed or refractory mantle-cell lymphoma, or who are aged >65 years and are newly diagnosed with the disease, may be eligible for enrollment if other criteria are met. Participants will receive ibrutinib plus rituximab.

The primary outcome measure is the ORR at 8 weeks. This study expects to enroll 100 patients at the University of Texas M.D. Anderson Cancer Center, Houston. For more information, call Michael Wang, MD, MS, at 713-792-2860. The NLM Identifier is NCT01880567.

4 Ibrutinib plus Ixazomib for Relapsed or Refractory Mantle­Cell Lymphoma

The purpose of this open-label, nonrandomized, parallel-assignment, phase 1/2 clinical trial is to determine the safety, efficacy, and maximum safe and tolerated dose of ibrutinib (Imbruvica) plus ixazomib (Ninlaro) in patients with relapsed or refractory mantle-cell lymphoma. Patients aged ≥18 years with pathologically proven mantle-cell lymphoma that was refractory to or relapsed after ≥1 treatments may be eligible for enrollment if other criteria are met. Participants will receive ibrutinib plus ixazomib.

The primary outcome measures are the maximum tolerated dose of ibrutinib plus ixazomib and the percentage of patients who achieve a complete response rate. The secondary outcome measures are ORR, PFS, OS, and adverse events. This study plans to enroll 84 patients at the McGlinn Cancer Institute at Reading Hospital, PA. For more information, contact Carolyn Andrews, RN, at 267-207-4070 or candrews@precogllc.org. The NLM Identifier is NCT03323151.

5 Obinutuzumab or Rituximab plus Idasanutlin and Venetoclax for Relapsed or Refractory Follicular or DLBCL

This nonrandomized, parallel-assignment, open-label, phase 1/2 clinical trial is evaluating the safety, efficacy, and pharmacokinetics of obinutuzumab (Gazyva) plus idasanutlin and venetoclax (Venclexta) in patients with relapsed or refractory lymphoma, and of obinutuzumab or rituximab (Rituxan) plus idasa­nutlin and venetoclax in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients aged ≥18 years with CD20-positive, relapsed or refractory follicular lymphoma or DLBCL and an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive obinutuzumab plus idasanutlin and venetoclax, or rituximab plus idasanutlin and venetoclax.

The primary outcome measures include the maximum tolerated doses of idasanutlin and venetoclax when combined with obinutuzumab or ri­tuximab, and the percentage of patients with a complete response. The secondary outcome measures include complete response rate, ORR, and the serum concentrations of rituximab and obinutuzumab in patients receiving either drug. This study plans to enroll 140 patients at multiple locations across the United States and abroad. For more information, call 888-662-6728 or e-mail global-­roche-genentech-trials@gene.com. The NLM Identifier is NCT03135262.

6 Efficacy of Axicabtagene Ciloleucel versus Standard Therapy in Relapsed or Refractory DLBCL

This randomized, open-label, parallel-assignment, phase 3 clinical trial will compare the efficacy of axicabtagene ciloleucel (Yescarta) with that of standard-of-care therapy in patients with relapsed or refractory DLBCL. Patients aged ≥18 years with histologically confirmed DLBCL, including transformation from follicular lymphoma, and an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive axicabtagene ciloleucel or standard therapy.

The primary outcome measure is event-free survival. The secondary outcome measures are ORR and OS. This study expects to enroll 350 patients at the Moffitt Cancer Center, Tampa, FL, and at Vanderbilt University, Nashville, TN. For more information, contact Kite Pharma at 844-454-5483 or medinfo@­kitepharma.com. The NLM Identifier is NCT03391466.

7 Safety and Efficacy of Axicabtagene Ciloleucel in Patients with Aggressive, Refractory NHL

This multicenter, open-label, single-group assignment, phase 1/2 clinical trial will assess the safety and efficacy of using axicabtagene ciloleucel (Yescarta) in patients with aggressive, refractory NHL. Patients aged ≥18 years with histologically confirmed, chemotherapy-refractory DLBCL, primary mediastinal large B-cell lymphoma, or transformation follicular lymphoma and an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive conditioning chemotherapy (ie, fludarabine [Fludara] and cyclophosphamide) followed by a single infusion of axicabtagene ciloleucel.

The primary outcome measures are ORR and the incidence of adverse events. The secondary outcome measures are OS, PFS, the incidence of adverse events, and the duration of response. This study expects to enroll 200 patients at multiple locations across the United States and abroad. For more information, contact Kite Pharma at 844-454-5483 or medinfo@­kitepharma.com. The NLM Identifier is NCT02348216.

8 ACTR707 plus Rituximab for Relapsed or Refractory CD20-Positive B-Cell Lymphoma

The purpose of this open-label, single-group assignment, multicenter, phase 1 clinical trial is to evaluate the safety and antilymphoma activity of ACTR707, an autologous T-cell drug, used in combination with rituximab (Rituxan) in patients with refractory or relapsed CD20-positive B-cell lymphoma. Patients aged 18 to 80 years with histologically confirmed, relapsed or refractory CD20-positive B-cell lymphoma and an ECOG performance status 0 or 1 may be eligible for enrollment if other criteria are met. Participants will receive ACTR707 in combination with rituximab.

The primary outcome measures are the safety of the combination therapy, the maximum tolerated dose, and the recommended phase 2 dose. The secondary outcome measures include the antilymphoma activity and persistence of ACTR707, and the plasma concentration of rituximab. This study expects to enroll 40 patients at Indiana Blood and Marrow Transplantation, Indianapolis, and Tennessee Oncology, Nashville. For more information, contact Francis Payumo at 530-868-6471 or francis.payumo@unumrx.com, or Michael Vasconcelles, MD, at 857-209-4741 or michael.vasconcelles@unumrx.com. The NLM Identifier is NCT03189836.

9 Front-Line Indolent B-Cell Lymphoma Therapy with Lenalidomide, Ixazomib, and Rituximab

The purpose of this open-label, single-group assignment, phase 1/2 clinical trial is to evaluate the use of lenalidomide (Revlimid), ixazomib (Ninlaro), and rituximab (Rituxan) as front-line therapy for patients with untreated, high-risk, indolent B-cell lymphoma. Patients aged ≥18 years with histologically confirmed, low-grade B-lymphocyte NHL and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive lenalidomide, ixazomib, and rituximab.

The primary outcome measure is the maximum tolerated dose and toxicity of ixazomib and lena­lidomide plus rituximab. The secondary outcome measures include ORR, PFS, OS, duration of response, time to progression, and time to treatment failure. This study expects to enroll 42 patients at 2 cancer centers in Ohio. For more information, contact Brian Hill, MD, PhD, at 216-444-9451 or Hillb2@ccf.org, or Paolo Caimi, MD, at 800-641-2422 or Paolo.Caimi@uhhospitals.org. The NLM Identifier is NCT02898259.

10 Safety and Efficacy of Copanlisib plus Rituximab in Relapsed Indolent B-Cell NHL

This randomized, parallel-assignment, double-blind, placebo-controlled, phase 3 clinical trial will determine whether copanlisib (Aliqopa) plus rituximab (Rituxan) is superior to placebo plus rituximab in prolonging the PFS of patients with relapsed, indolent B-cell NHL, as well as the safety and efficacy of copanlisib itself. Patients aged ≥18 years with histologically confirmed, CD20-positive, indolent NHL and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive rituximab and either copanlisib or placebo.

The primary outcome measure is PFS. The secondary outcome measures include OS, objective tumor response, complete response, and duration of response. This study expects to enroll 567 patients at multiple locations across the United States and abroad. For more information, contact Bayer Clinical Trials at 888-842-2937. The NLM Identifier is NCT02367040.

11 Obinutuzumab plus Venetoclax and Lenalidomide for Relapsed or Refractory B-Cell NHL

The purpose of this open-label, single-group assignment, phase 1 clinical trial is to evaluate the side effects and best dose of venetoclax (Venclexta) and lenalidomide (Revlimid) when combined with obinutuzumab (Gazyva) for the treatment of patients with relapsed or refractory B-cell NHL. Patients aged ≥18 years with histologically confirmed B-cell NHL and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive lenalidomide, venetoclax, and obinutuzumab.

The primary outcome measure is the maximum tolerated dose of obi­nutuzumab plus venetoclax and lenalidomide. The secondary outcome measures are ORR and PFS. This study expects to enroll 60 patients at the Ohio State University Comprehensive Cancer Center, Columbus. For more information, contact the Ohio State University Comprehensive Cancer Center at 800-293-5066 or OSUCCCClinicaltrials@osumc.edu. The NLM Identifier is NCT02992522.

12 Ibrutinib plus Rituximab and Lenalidomide for Untreated Follicular or Marginal-Zone Lymphoma

This open-label, single-group assignment, phase 2 clinical trial assesses whether adding ibrutinib (Imbruvica) to rituximab (Rituxan) and lenalidomide (Revlimid) can help control disease in untreated patients with follicular or marginal-zone lymphoma. Patients aged ≥18 years with untreated, histologically confirmed, CD20-­positive follicular or marginal-zone lymphoma and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive rituximab and lenalidomide plus ibrutinib.

The primary outcome measure is PFS. The secondary outcome measure is complete response. This study expects to enroll 60 patients at the University of Texas M.D. Anderson Cancer Center, Houston. For more information, call Loretta Nastoupil, MD, at 713-792-2860. The NLM Identifier is NCT02532257.

13 Romidepsin plus Brentuximab Vedotin for Cutaneous T-Cell Lymphoma

The purpose of this open-label, single-group assignment, phase 1 clinical trial is to evaluate the feasibility of combining romidepsin (Istodax) with brentuximab vedotin (Adcetris) in patients who require systemic therapy for cutaneous T-cell lymphoma. Patients aged ≥18 years with histologically or cytologically confirmed mycosis fungoides, Sézary syndrome, or primary cutaneous CD30-positive lymphoproliferative disorder may be eligible for enrollment if other criteria are met. Patients will receive romi­depsin plus brentuximab vedotin.

The primary outcome measures are the maximum tolerated dose and dose-limiting toxicities. The secondary outcome measures include OS, PFS, and the overall safety and tolerability of the combination therapy. This study plans to enroll 27 patients at the Fox Chase Cancer Center, Philadelphia, PA. For more information, contact Stefan K. Barta, MD, at 215-728-2674 or stefan.barta@fccc.edu. The NLM Identifier is NCT02616965.

14 Gemcitabine plus Clofarabine and Busulfan for Aggressive Lymphomas

The purpose of this single-group assignment, open-label, phase 1/2 clinical trial is to determine the highest tolerable dose of gemcitabine (Gemzar) that patients with aggressive lymphomas can receive in combination with fixed doses of busulfan (Myleran) and clofarabine (Clolar) before allogeneic stem-cell transplantation. Patients aged 12 to 65 years with refractory B-cell or T-cell NHL or Hodgkin lymphoma who are eligible for allogeneic stem-cell transplantation may be eligible for enrollment if other criteria are met. Participants will receive gemcitabine plus clofarabine and busulfan.

The primary outcome measure is the maximum tolerated dose of gemcitabine that can be administered in combination with fixed doses of clofarabine and busulfan. The secondary outcome measures include the success rate of the treatment, defined as the rates of event-free survival, OS, ORR, and complete response, and the percentage of patients who are alive, engrafted, and without grade 3 to 4 graft-versus-host disease. This study plans to enroll 80 patients at the University of Texas M.D. Anderson Cancer Center, Houston. For more information, call Yago Nieto, MD, PhD, at 713-792-8750. The NLM Identifier is NCT01701986.

15 Ceritinib plus Brentuximab Vedotin for ALK-Positive Anaplastic Large-Cell Lymphoma

This open-label, single-group assignment, phase 1/2 clinical trial will determine the side effects and best dose of ceritinib (Zykadia) when administered in combination with brentuximab vedotin (Adcetris) for the treatment of patients with untreated, ALK-positive anaplastic large-cell lymphoma. Patients aged ≥12 years with untreated, histologically confirmed ALK-positive CD30-positive anaplastic large-cell lymphoma and an ECOG performance status 0 to 3 may be eligible for enrollment if other criteria are met. Participants will receive ceritinib and brentuximab vedotin.

The primary outcome measures are ORR, complete remission rate, and maximum tolerated dose of ceritinib and brentuximab vedotin. The secondary outcome measures are OS, PFS, incidence of adverse events, and laboratory abnormalities. This study expects to enroll 30 patients at the Fred Hutchinson/University of Washington Cancer Consortium, Seattle. For more information, contact Andrei R. Shustov at 206-606-6744 or ashustov@u.washington.edu. The NLM Identifier is NCT02729961.

16 Everolimus plus Brentuximab Vedotin for Relapsed or Refractory Hodgkin Lymphoma

The purpose of this open-label, single-group assignment, phase 1 clinical trial is to evaluate the use of everolimus (Afinitor) in combination with brentuximab vedotin (Adcetris) in patients with relapsed or refractory Hodgkin lymphoma. Patients aged ≥18 years with relapsed, refractory, or residual Hodgkin lymphoma determined via biopsy and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive everolimus and brentuximab vedotin.

The primary outcome measures are the maximum tolerated dose and safety of everolimus administered in combination with brentuximab vedotin. The secondary outcome measures include complete response, ORR, and PFS. This study expects to enroll 26 patients at the Mayo Clinic, Rochester, MN. For more information, call the Clinical Trials Referral Office at 855-776-0015. The NLM Identifier is NCT02254239.

17 Adding Selinexor to the RICE Regimen for Relapsed or Refractory Aggressive B-Cell Lymphomas

The purpose of this open-label, single-group assignment, phase 1 clinical trial is to evaluate the use of the investigational drug selinexor in combination with rituximab (Rituxan), etoposide, carboplatin, ifosfamide, and dexamethasone (RICE) chemotherapy for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma. Patients aged ≥18 years with histologically confirmed, aggressive B-cell NHL and an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Participants will receive selinexor and the RICE chemotherapy regimen.

The primary outcome measure is the maximum tolerated dose of selinexor when combined with RICE chemotherapy. The secondary outcome measures include OS and PFS. This study expects to enroll 18 patients at the Weill Cornell Medical College, New York. For more information, contact Amelyn Rodriguez, RN, at 212-746-1362 or amr2017@med.cornell.edu, or Rita Gazivoda, RN, at 212-746-0702 or rig9021@med.cornell.edu. The NLM Identifier is NCT02471911.