Lymphoma

Clinical Trials

2013-1008

Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the BTK Inhibitor, Ibrutinib, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma.

DescriptionThis is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to compare the efficacy and safety of ibrutinib in combination with R-CHOP versus R-CHOP alone in subjects 18 years and older with newly diagnosed non-GCB DLBCL, as confirmed by central IHC. Approximately 800 eligible subjects will be randomly assigned in this study, with 400 subjects planned per treatment arm. The study will include a Pretreatment (Screening) Phase, Active Treatment Phase, and a Posttreatment Follow-up Phase. The Active Treatment Phase will extend from Day 1 Cycle 1 until study drug discontinuation due to disease progression, initiation of subsequent antilymphoma therapy, unacceptable toxicity, withdrawn, or completion of study drug.

For information on this study from ClinicalTrials.gov, click here!

2012-1546 

Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Idelalisib (CAL 101) in Combination with Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas 

Description: The purpose of this study is to evaluate the efficacy and safety of adding Idelalisib to rituximab in patients with previously treated recurrent indolent non-Hodgkin lymphoma (iNHL). This study is being conducted to evaluate the efficacy and safety of adding GS-1101 to rituximab in patients with previously treated, recurrent indolent non-Hodjin lymphoma (iNHL). This research study is evaluating a study drug (not yet approved by the FDA), called GS-1101 (also known as CAL-101) in combination with a standard drug, called rituximab, as a possible treatment for patients with iNHL. All subjects will receive rituximab by intravenous infusions. Subjects will be randomized (like the flip of a coin) to either GS-1101 or placebo (a tablet that looks like GS-1101 but contains no active medicine) that is taken twice a day.

For information on this study from ClinicalTrials.gov, click here!

Pro-527

Title: ECOG E1411: Intergroup Randomized Phase II Four Arm Study in Patients >/= 60 with Previously Untreated Mantle Cell Lymphoma

Description: This study is for patients with untreated mantle cell lymphoma who are at least 60 years of age. The purpose of this study is two- fold and has two steps of treatment: 1) In step 1, to find out what effects the addition of bortezomib to rituximab plus bendamustine has on mantle cell lymphoma compared to rituximab plus bendamustine alone. 2) In step 2, to find out what effects continuing treatment after step 1 with lenalidomide plus rituximab has on mantle cell lymphoma compared to continuing treatment with rituximab alone. Subjects on this study will be randomized (like the flip of a con) to receive one of the following regimens: 1) Step 1 rituximab plus bendamustine, followed by step 2 rituximab 2) Step 1 bortezomib plus rituximab plus bendamustine, followed by step 2 rituximab 3) Step 1 rituximab plus bendamustine, flowed by step 2 lenalidomide plus rituximab 4) Step 1 bortezomib plus rituximab plus bendamustine, flowed by step 2 lenalidmide plus rituximab These regimens are experimental and have not been approved by the FDA for use in patients with untreated mantle cell lymphoma, although each of these drugs used in this study is FDA approved for certain blood cancers.

For information on this study from ClinicalTrials.gov, click here!

2012-1085

Title: A Randomized, Open Label, MultiCenter, Phase II Trial Evaluating the Safety and Activity of DCDT2980S in Combination with Rituximab or DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma.

Description: This study is for patients with an advanced stage of non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has come back after standard treatment. The purpose of this study is to test two experimental drugs called DCDT2980S and DCDS4501A, each in combination with another drug, rituximab (Rituxan®, MabThera®). We want to find out what effects, good and/or bad, these drugs have on you and your cancer.DCDT2980S and DCDS4501A are drugs manufactured by Genentech and are designed to prevent or slow down tumor growth. The drugs target specific markers on the surface of your tumor cells. DCDT2980S targets a molecule called CD22 (or the CD22 antigen), and DCDS4501A targets a molecule called CD79b (or the CD79b antigen). In laboratory experiments and in animal studies, DCDT2980S and DCDS4501A were shown to reduce the growth of a number of B-cell malignancies including lymphoma. The use of DCDT2980S and DCDS4501A in this research study is experimental, which means that both drugs are not approved by the U.S. Food and Drug Administration (FDA) for cancer or for any other disease. DCDT2980S and DCDS4501A, each in combination with rituximab, have been previously tested in clinical trials to determine a dose that is safe when given to humans. There is currently not enough information to know how well DCDT2980S and DCDS4501A work against tumors in people. Furthermore, it is not known whether DCDT2980S or DCDS4501A, when each is combined with rituximab, is safer and more effective against your tumor than rituximab alone. This will be tested in this clinical trial. Rituximab, also known as Rituxan or MabThera, is approved by the U.S. FDA and other health regulatory bodies around the world for the treatment of certain types of non-Hodgkins lymphoma (NHL). Rituximab was tested in combination with DCDT2980S or DCDS4501A. However, information on the combination is limited, which is the reason why this study is being conducted. An optional research study. Genentech, the study sponsor, would like to collect a sample of your blood and sections of your cancer tissue for future research to learn more about the You are also being asked to take part in an optional research study. Genentech, the study sponsor, would like to collect a sample of your blood and sections of your cancer tissue for future research to learn more about the development of cancer and predictors of response.

For more information on this trial from ClinicalTrials.gov, click here!

2013-0620

Title: C25003- A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

DescriptionThe main purpose of this study is to measure how well treatment in Arm A works compared to treatment in Arm B for Hodgkin lymphoma.

In this study, Subjects will receive one of two regimens, either a regimen that includes an investigational drug called brentuximab vedotin (also known as ADCETRIS®) (this regimen/group is referred to as Arm A) or a commonly prescribed regimen (this regimen/group is referred to as Arm B) – these regimens will be described in more detail in section 3. ADCETRIS has been approved in the United States by the Food and Drug Administration (FDA) as ADCETRIS for treatment of some types of lymphoma in patients where other therapies have failed. The use of ADCETRIS in this study is experimental, which means that the drug has not been approved by the FDA for use in patients that have not received any treatment for their HL (also known as frontline therapy).

In this study, subjects may be treated with the investigational drug, ADCETRIS, which targets CD30, a protein on the surface of certain cells (a “marker”) that is found on some types of cancers such as Hodgkin lymphoma (HL). ADCETRIS targets CD30 on the cancer cell surface and may cause the cancer cells to die.

For information on this study from ClinicalTrials.gov, click here!

2013-0432

Title: A051103: A Phase I Study of Rituximab, Lenalidomide, and Ibrutinib in Previously Untreated Follicular Lymphoma.

DescriptionThe purpose of this study is to test the safety of giving the drugs lenalidomide and ibrutinib with the drug rituximab. We want to find out what effects, good and/or bad, they have on subjects and their follicular lymphoma. The primary purpose of this study is to identify the highest doses of lenalidomide and ibrutinib that can be given safely with rituximab. Rituximab is approved by the Food and Drug Administration (FDA) for treatment of follicular NHL when given along with other chemotherapy drugs. Lenalidomide has not been approved by the FDA for use in follicular NHL and its use in this study is experimental. Ibrutinib has not been approved by the FDA for use in follicular NHL and its use in this study is experimental. The combination of lenalidomide, ibrutinib, and rituximab is experimental.

For information on this study from ClinicalTrials.gov, click here!

2014-0778

Title: ACE-WM-001: An Open-Label, Phase 1b Study of ACP-196 in Subjects with Waldenstrom Macroglobulinemia

Description: This study is for patients with a type of blood cancer called Waldenstrom's macroglobulinemia (WM) that has relapsed (come back) or failed to respond to anticancer therapy. The purpose of the study is to find out if the study drug, ACP-196 will slow or stop the cancer from getting worse and whether the study drug has side effects. ACP-196, is a type of drug that blocks proteins inside cells that help cells live and grow. All subjects on this study will receive study drug as a pill. Some subjects will be asked to take the pills once a day and some will be asked to take the pills twice a day.

For information on this study from ClinicalTrials.gov, click here!

2014-0501

Title: A Phase 1b, Multicenter, Open-label Study of 2 Dosing Regimens of ACP 196 in Subjects with Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Description: The protocol is for patients with ABC diffuse large B-cell lymphoma (ABC DLBCL) that has relapsed (come back) or failed to respond to standard anticancer therapy.

The purpose of the study is to find out if the study drug, ACP-196 will slow or stop the cancer from getting worse and whether the study drug has side effects. ACP-196, is a type of drug that blocks proteins inside cells that help cells live and grow.

All subjects on this study will receive study drug as a pill. Some subjects will be asked to take the pills once a day and some will be asked to take the pills twice a day.

2015-0487

TitleGO29687: An Open Label, Multicenter, Phase I/IB Dose Escalation Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Preliminary Efficacy of DCDS0780A Alone, or in Combination with Rituximab, in Patients with Relapsed/ Refractory B-Cell Non-Hodgkin’s Lymphoma

Description: This study is for patients with non-Hodgkin’s lymphoma (NHL) that has relapsed after or failed to respond to at least one prior treatment regimen. The purpose of this study is to test the safety of DCDS0780A at different dose levels and find out what effects, good and/or bad, DCDS0780A alone or in combination with rituximab has.

For information on this study from ClinicalTrials.gov, click here!