Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Hodgkin Disease

Waldenstrom Macroglobulinemia

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Hodgkin Lymphoma

People that have blood or lymph node cancer, or a family history of leukemia or lymphoma.

Douglas R Stewart, M.D.

Background:

* Individuals may be prone to develop blood or lymph node cancers (leukemia or lymphoma) for a variety of reasons, including genetic predisposition to these cancers, environmental exposures or other medical conditions.
* Studies of people and families at high risk of cancer often lead to clues about their cause that may also be important regarding the sporadic occurrence of these cancers in the general population.
* Identifying genetic or environmental factors that play a role in the development of these diseases may be important in developing prevention trials, screening programs and treatments.

Objectives:

* Describe the cancers and other conditions in families with blood or lymph node cancer.
* Find and describe genes that may cause blood and lymph node cancer, and understand how they work in families.
* Use laboratory methods to try to determine if it is possible to identify who is at highest risk of blood or lymph node cancer.
* Test how genes act with other factors to alter the risk of disease, its severity or its manifestations in families.

Eligibility:

* Individuals of any age with a personal or family history of a blood or lymph node cancer.
* Individuals with a personal or family history of medical conditions or environmental exposures that may predispose to blood or lymph node cancer.

Design:

* Participants complete questionnaires about their personal and family medical history and provide consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with blood or lymph node cancer, tumors, or other related illnesses for whom they are the legally authorized representative.
* Participants donate a sample of blood or cheek cells, or a lock of hair for genetic studies.
* Patients may also be evaluated at the NIH Clinical Center by one or more of the following specialists: cancer doctor or blood specialist, medical geneticist, research nurses or clinical social worker. They may have blood and urine tests and a cheek swab or mouth wash to collect cheek cells. Some patients may also be asked to have x-rays and routine imaging, such as CT scans or ultrasound tests, cell surface markers, skin biopsy, and, with special consents, bone marrow biopsy, MRI or PET scans, apheresis or fluorescein angiography and photography.

Background:

Persons may be prone to develop hematologic or lymphoproliferative cancer for a variety of reasons including: inherited predisposition of benign, premalignant, or malignant conditions; environmental exposures shared by family members; previous tumors or preneoplastic conditions; immune deficiency; or stochastic processes

Investigations of individuals and families at high risk of cancer often lead to etiologic clues that may be important in the sporadic counterparts of these cancers in the general population

Identification of etiologically important genetic factors could inform chemoprevention trials, screening programs, and treatment of hematologic and lymphoproliferative cancers

Objectives:

To evaluate and define the clinical spectrum and natural history of disease in syndromes predisposing to hematologic cancer

To evaluate potential precursor states of malignancy in families at risk

To quantify the risks of specific tumors in family members and define syndromic constellations

To identify, map, characterize, clone, and determine function of tumor susceptibility genes

To validate and test associations of biomarkers with risk

To identify genetic determinants, environmental factors, and gene-environmental interactions conferring cancer risk in individuals and families

To identify differences and similarities between the familial and sporadic condition

To educate and counsel study participants about their risk of hematologic malignancy including prevention recommendations and early detection activities when known

To develop syndrome-specific educational materials for medical professionals and high-risk family members

Eligibility:

On referral, persons \>= 11 months will be included only because of personal history, and persons \>/=18 years can also be included because of personal or family history of the parameters listed below:

* a medical history of hematologic/lymphoproliferative malignancy of an unusual type, pattern, or number or
* there are known or suspected factor(s) predisposing to hematologic malignancy, either genetic or congenital factors, environmental exposure, or unusual demographic features

  * For familial neoplasms, two or more living affected cases among family members are generally required

Design:

This is a prospective study. Families are studied long-term using a cohort approach.

The study design and evaluation vary by the specific type of familial neoplasm being studied

The overall approach to eligible families includes defining affection status, characterization of disease, localization of genetic loci, identification of genes, evaluation of phenotype/genotype correlations, estimation of risk of the disease associated with carrier

status and identification of other risk factors that modify penetrance (genetic, environmental, and host factors)

Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer

Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Blood and Lymph Node Malignancy

To define the clinical spectrum and natural history of familial blood and lymph node malignancies and susceptibility states over time.

National Cancer Institute (NCI)

Infections

Epstein-Barr Virus Infections

Virus Diseases

Communicable Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

PD1 inhibitor - nivolumab 3 mg/kg (max dose: 240 mg) Q 2 weeks for total 4 doses and repeat a day prior to each EBVST infusion.

EBVST- 1 x 10\^8/m2 at days +1 and +15. PD1 inhibitor - nivolumab 3 mg/kg (max dose: 240 mg) Q 2 weeks for total 4 doses and repeat a day prior to each EBVST infusion.

Can receive up to 3 additional infusions of EBVSTs with a single dose of nivolumab at 6-12 week intervals starting at least 6 weeks after the second infusion if stable disease or a partial response at Week 8 evaluation

EBVST cells in an expected volume of 10-20cc will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.

EBVST Cells

Nivolumab 3mg/kg (max dose: 240 mg) will be administered as an intravenous infusion over 60 minutes.

Ravi Pingali, MD

Subjects have a type of a lymph node cancer called Non-Hodgkin's Lymphoma (NHL) or lymphoproliferative disease (LPD), which affects their immunity, blood production, and can involve multiple other organs in the body. Their disease has come back or has not gone away after treatment. The experimental treatment plan consists of an antibody therapy called "Nivolumab" that helps the subjects' T-cells control the tumor, and special immune system cells called EBV-specific cytotoxic T lymphocytes, also a new therapy whose side effects are well studied.

Some patients with NHL or LPD are infected with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. The cancer cells that are infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor.

Investigators have used this sort of therapy to treat a different type of cancer that occurs after bone marrow or solid organ transplant called post-transplant lymphoma with good success. These cells are called EBV-specific cytotoxic T-lymphocytes (EBVSTs), and are effective in treating these diseases. These EBVSTs are experimental and not yet approved by the Food and Drug Administration (FDA).

Sometimes it is not possible to grow these cells; or they may not last very long in the body after being given into the vein thereby having only limited time to fight the tumor. With this study, investigators aim to increase the duration of time that the T cells can last in the body and can effectively fight the cancer by using nivolumab. Nivolumab is FDA approved for treatment of other kinds of cancer like lung cancer and a skin cancer called Melanoma.

The purpose of this study is to find out if EBVST cells in combination with nivolumab are safe, to learn what the side effects are, and to see whether this therapy may help patients with EBV related lymphoma or LPD.

The investigators will draw blood from the subject to make EBV-specific cytotoxic T-lymphocytes (EBVSTs) in the lab. Investigators will make the cells by first growing a special type of cells called dendritic cells (DCs) or monocytes to stimulate the T cells. Then they will add specially produced mixtures of proteins that included the LMP, EBNA1, and BARF proteins. These are used to stimulate T cells. As the T cells grow, investigators add some of the subject's cells expressing these proteins to stimulate them. They also add a cell called K562 that has had new genes put inside it so it expresses proteins that stimulate the immune system to encourage the T cells to grow. This stimulation trains the EBVSTs to kill cells with EBV proteins on their surface. These cells will be grown and frozen.

The cells grown in the lab will be thawed and injected into the subject's vein over 2-10 minutes. Initially, one dose of the drug nivolumab is given one day before the EBVST cells are infused (on day 0) and then every 2 weeks for a total of four doses of nivolumab. Subjects will receive two infusions of the EBVST cells. The first infusion will be given on Day 1 and a second infusion of T cells on Day 15.

If eligible, subjects may receive up to three additional doses of the T cells 6-12 weeks apart and each additional T cell infusion would be preceded by one dose of nivolumab a day prior.

Subjects will have medical and blood tests at predetermined time points. Investigators will follow subjects closely after treatment for any side effects for at least for 1 year after the subject's last infusion.

Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE)

Phase I Study Combining Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS) in Relapsed/Refractory EBV Positive Lymphoma Patients (PREVALE)

For the purpose of this study, dose limiting toxicity will be defined as any of the below listed items considered to be primarily related to the EBVST infusion or Nivolumab:

* CTCAE grade 3-4 diarrhea needing steroids for more than 1 week or needing hospitalization for more than 1 week,
* Pancreatitis of any grade needing hospitalization,
* Pneumonitis needing hospitalization for more than a week or needing home oxygen despite appropriate treatment for 1 week.
* Hepatitis grade 3 or more not resolving in 2 weeks after discontinuation of therapy,
* Stomatitis/mucositis needing TPN.
* Musculoskeletal symptoms affecting activities of daily living for more than 2 weeks after discontinuation of therapy.

The duration of overall response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Baylor College of Medicine

Director CAGT

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

45 Gy in 25 fractions of 1.8 Gy per fraction over 5 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

36 Gy in 20 fractions of 1.8 Gy per fraction over 4 weeks Involved Field radiotherapy (IFRT)/ Involved Site Radiotherapy (ISRT)

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Standard Arm

Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.

Experimental Arm

Jayant Sastri Goda, M.D

Sidharth Laskar, M.D

Jayant Goda, M.D.

The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions.

The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.

Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma (DOBL) - A Randomised Phase III Non- Inferiority Trial.

From the time of randomization till relapse or progression or death due to any cause or death due to disease.

Assessment by physiological parameter

From the time of randomization till the disease is controlled at the site of radiation.

Assessment by physiological parameter.

From the time of randomization to death due to any cause /death due to disease. assessment by physiological parameter

Tata Memorial Hospital

Associate Professor

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Vulvar Neoplasms

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Breast Diseases

Skin Diseases

Fallopian Tube Diseases

Vulvar Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Vulvar Cancer

Includes: cervical cancer, endometrial cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer and vulval cancer

The purpose of this study is to invite all people diagnosed with cancer who meet the eligibility criteria to complete questionnaires before their treatment begins and at regular intervals over time to assess the impact of cancer and its treatment on people's lives in the short, medium and long term. We will explore a range of factors to determine their role in both recovery of health and well-being and self-management. Although it is known that people who have had cancer are likely to experience a number of physical and psychological problems as a result of the disease and treatment, it is not known what the 'typical' course of recovery of health and well-being looks like, how long it takes and how this can be influenced. We will determine pathways to recovery of health and well-being following cancer diagnosis (initially breast cancer diagnosed \<50 years, Non-Hodgkin Lymphoma and gynaecological cancers) and identify what factors influence this. This includes assessing the relative importance of the person's illness, personal attributes, perceived burden of treatment, role of the environment they live in, including health / social care and personal networks of support, and their ability and capacity to self-manage. We will identify who is most at risk of problems and what environmental supports and resources people are able to mobilise to support their self-management. We will also explore who has the confidence and ability to manage during and beyond treatment and what factors influence this and whether this leads to earlier problem resolution and restoration of health and well-being. This knowledge will be used to develop and test future supportive interventions to enhance the rapid recovery of health and well-being - our long term aim being to design ways of helping people with cancer in areas we identify as problematic for them.

HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life

HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer

We encourage and facilitate data sharing by researchers from all disciplines.

More detail can be found on our website: http://horizons-hub.org.uk/access_data.html

If you have further questions about this process please contact us on 023 8059 6885 or msrg@soton.ac.uk.

Primary outcome measure which assesses the quality of life in adult cancer survivors. It is comprised of 12 domains regarding cancer survivorship: generic (pain, fatigue, positive and negative feelings, cognitive and sexual problems, social avoidance) and cancer-specific (financial problems, family distress, recurrence distress, appearance concerns, benefits from cancer).

Changes will be assessed at the following time-points:

* Baseline (following diagnosis but pre-treatment)
* 3 months after baseline (to monitor early adaptation and coping)
* 12 months after baseline (to monitor coping and further adaptation)
* 18 months after baseline (to explore early stages of recovery)
* 24 months after baseline and further annual assessments (to monitor consequences in the longer term and how they are managed)

Assesses health status for clinical and economic appraisal. Includes five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and five levels of severity.

Captures the impact of cancer and its treatment with 30 items assessing function (physical, role, cognitive, emotional, and social), symptoms (e.g. fatigue, pain, and nausea and vomiting) as well as global health and QoL.

Site-specific modules included to capture disease-specific consequences for Breast, Cervical, Endometrial, Ovarian and Vulval cancers, as well as High Grade Non-Hodgkin's Lymphoma (NHL). Modules will be supplemented with additional items from the EORTC item library to assess consequences not otherwise captured.

Comprises of 14 items with two 7-item subscales assessing anxiety and depression symptoms.

Assesses the level of social support available and covers 4 domains (emotional/informational, tangible, affectionate support and positive social interaction).

SEMCD evaluates self-efficacy among patients with chronic medical conditions; whilst the CS-SES examines self-efficacy with reference to cancer-specific issues.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer	NCT00039676	Waldenstrom Mac... Chronic Lymphoc... Hodgkin Disease NonHodgkin Lymp... Mixed Lymphopro...		11 Months -	National Institutes of Health Clinical Center (CC)
Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE)	NCT02973113	NonHodgkin Lymp... Lymphoprolifera... EBV Related Lym... EBV-Related PTL... Hodgkin Lymphom... EBV Related Non... EBV Related Hod...	EBVST Cells Nivolumab	-	Baylor College of Medicine
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.	NCT02964858	NonHodgkin Lymp...	Standard Arm Experimental Ar...	18 Years - 65 Years	Tata Memorial Hospital
Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.	NCT02964858	NonHodgkin Lymp...	Standard Arm Experimental Ar...	18 Years - 65 Years	Tata Memorial Hospital
HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life	NCT03000192	Breast Cancer F... Breast Neoplasm Non-Hodgkin's B... Non-Hodgkin's L... NonHodgkin Lymp... Diffuse Large B... Diffuse Large C... Ovarian Cancer Ovarian Neoplas... Endometrial Can... Endometrial Neo... Cervical Cancer Cervical Neopla... Primary Periton... Fallopian Tube ... Fallopian Tube ... Vulvar Cancer Vulvar Neoplasm...		16 Years -	University Hospital Southampton NHS Foundation Trust
Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE)	NCT02973113	NonHodgkin Lymp... Lymphoprolifera... EBV Related Lym... EBV-Related PTL... Hodgkin Lymphom... EBV Related Non... EBV Related Hod...	EBVST Cells Nivolumab	-	Baylor College of Medicine

Spots Global Cancer Trial Database for nonhodgkin lymphoma