Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Lymphoma


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drug discontinuation due to disease progression, initiation of subsequent antilymphoma therapy, unacceptable toxicity, withdrawn, or completion of study drug.

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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.

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Contact: Ramzi Pari, NP
Email: ramzip1@georgetown.edu
Phone: 202-784-0038

2013-0583 

Title: A051201: A Phase I/Randomized Phase II Trial of Idelalisib, Lenolidomide, and Rituximab in Relapsed/Refractory Mantle Cell Lymphoma

Description: The purpose of this study is to test the safety of the combination of the drugs lenalidomide and idelalisib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on you and your lymphoma.

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Contact: Jenny Crawford
Email: crawfojg@georgetown.edu
Phone: 202-687-0893

2010-082

Title: GAO4753g: An open-label, multicenter, randomized, phase III study to investigate the efficacy and safety of bendamustine compared with bendamustine + RO5072759 (GA101) in patients with rituximab-refractory, indolent Non-Hodgkin's Lymphoma

Description: The study will evaluate the efficacy and safety of bendamustine with or without the study drug GA101 in patients with rituximab-refractory, indolent non-Hodgkin's lymphoma. The patients in this study will be "randomized" into one of the study groups. It is like flipping a coin. Which group an individual patient is placed in is done by a computer. Neither the patient nor the researchers will choose what group an individual patient will be in. Patients in group 1 will receive bendamustine alone. In group 2, patients will receive bendamustine combined with GA101. All patients will be assessed for disease progression and questionnaires will be completed to evaluate the patient outcome.

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2012-1513 

Title: An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects with Refractory Follicular Lymphoma 

Description: The main purpose of this study is to assess the effects (both good and bad) of PCI-32765 in follicular lymphoma and whether the follicular lymphoma responds to this treatment. All subjects in this study will receive treatment with PCI-32765. Your study doctor will see you every 21 days to check your progress and give you more PCI-32765. This 21-day period is called a cycle. You will be asked to take 4 capsules each day at home apart from the study visits at the first three visits (cycle 1, 2, and 3). After a year your study doctor will see you every two cycles.

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Contact: Ramzi Pari
Email: ramzip1@georgetown.edu
Phone: 202-784-0038

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.

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Contacts:
Jenny Crawford, Pari Ramzi
Email: crawfojg@georgetown.eduramzip1@georgetown.edu
Phone: 202-687-0893/202-784-0038

2012-1085

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.

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.

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Contact: Lombardi Cancer Line
Email: LombardiCancerLine@gunet.georgetown.edu
Phone: 202-444-4000

2013-0699 

Title: An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma 

Description: This is a multicenter, open-label, early access treatment protocol of single-agent ibrutinib in subjects with relapsed or refractory MCL who reside in areas where ibrutinib is not yet commercially available through local healthcare providers, and who are not eligible for enrollment in another ongoing clinical study of ibrutinib. It is anticipated that approximately 250 subjects will participate in this early access treatment protocol, although the number will be determined by medical need and the timing of health authority approvals and reimbursement authorizations for the use of ibrutinib. Eligibility will be determined during the Screening Phase. During the Treatment Phase, eligible subjects will receive 560 mg oral ibrutinib once daily until disease progression, occurrence of unacceptable toxicity, the subject is no longer receiving clinical benefit, or the end of study (see end of study definition). A treatment cycle is defined as 28-day continuous (without interruption) self-administered treatment. Doses can be held or reduced based on the severity of and the recovery from a previous toxicity. Dose re-escalation is not allowed.

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Contact: Jeanette Crawford
Email: crawfojg@georgetown.edu
Phone: 202-687-0893

2013-0582

Title: A051202: A Phase I Trial of Lenalidomide, Rituximab, and Idelalisib in Recurrent Follicular Lymphoma

DescriptionThe purpose of this study is to test the safety of the combination of the drugs lenalidomide and idelalisib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on you and your follicular lymphoma. The primary objective of this study is to determine the maximum tolerated dose of lenalidomide when combined with rituximab and idelalisib in patients with recurrent follicular NHL.

While the Food and Drug Administration (FDA) has approved rituximab for use in this disease, the FDA has not approved lenalidomide and idelalisib for use in this disease. The use of lenalidomide and idelalisib is considered experimental.

Data from previous studies suggest that idelalisib cab be easily combined with other agents (including rituximab) resulting in very high clinical activity in folicular and other indolent lymphomas.

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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.

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2013-0432

Title: 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.

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2010-392

Title: CALGB 50803: A Phase II Trial of Lenalidomide (Revlimid, CC-5013) (NSC #703813, IND #70116) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL). 

DescriptionThis study is for patients with newly diagnosed follicular non-Hodgkin lymphoma (NHL). The purpose of this study is to find out what effects the combination of lenalidomide and rituximab has on follicular non-Hodgkin's Lymphoma.

Rituximab is approved by the Food and Drug Administration (FDA) for treatment of follicular NHL that does not respond to treatment or has come back after treatment. Rituximab is a monoclonal antibody. Monoclonal antibodies are made in the laboratory and can bind to substances in the body, including cancer cells. Rituximab binds to the protein called CD20, which is found in B-cells, and may kill cancer cells.

Lenalidomide has not been approved by the FDA use in follicular lymphoma, and its use in this study is experimental. However, Lenalidomide is approved by the FDA for treatment of multiple myeloma (MM) and other myelodysplastic syndromes (MDS) and has been shown to be effective in lymphoma that does not respond to treatment or has come back after treatment. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Laboratory studies suggest that the combination of lenalidomide plus rituximab might improve anti-lymphoma effects over rituximab alone. All subjects on this study will receive both drugs.

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2010-182

Title: Prospective, Longitudinal, Multinational Registry of Patients with Newly Diagnosed Peripheral T-Cell Lymphoma. 

DescriptionThe purpose of the study is to describe, in detail, pasterns of care for patients with peripheral T cell lymphoma. This study consists of a registry called the PTCL registry. The PTCL registry is directed at providing detailed information on patient characteristics, treatments and outcomes. It is expected that approximately 75 sites will participate in the registry. The precise number of patients who will participate in the registry is not known at the present time. There are an estimated 6000 new cases of T cell lymphoma diagnosed each year in US and a comparable number in the 5 large countries of western Europe.

Information that is obtained from the registry can provide details for a population of patients in the 'real world' and can be particularly useful in describing strategies actually being employed and tracking their outcomes. The PTCL registry is expected to further the understanding of PTCL and influence the design of future clinical trials. The registry holds the promise of eventually documenting best practices for patient care.

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