Infections

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Epstein-Barr Virus Infections

Virus Diseases

Lymphohistiocytosis, Hemophagocytic

Communicable Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Histiocytosis

Histiocytosis, Non-Langerhans-Cell

Lymphatic Diseases

Non-Langerhans-Cell Histiocytosis

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Etoposide

Doxorubicin

Liposomal doxorubicin

Prednisolone

Pegaspargase

Etoposide phosphate

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Protective Agents

Pegaspargase 2000U/m2 day5; doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

doxorubicin

100 mg/m2 was administered once on the first day of every week

etoposide

15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

methylprednisolone

jingshi wang, M.M.

zhao wang, M.D.

This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis

A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).

A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×109/L, a response was defined as an increase by at least 100% to\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \>2.0 × 109/L was considered a response; and for patients with ALT \>400 U/L, response was defined as an ALT decrease of at least 50%.

Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.

Beijing Friendship Hospital

Doctor

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Recurrence

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Pharmaceutical Solutions

Bevacizumab

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Intravenous pembrolizumab alone,D8 of 21-day cycle.

Intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle).

pembrolizumab

* Bevacizumab in Concentrate for Solution
* Bevacizumab in Concentrate for Solution

bevacizumab

Boon Cher Goh

This is a single center, randomized, phase Ib/II open-label study of pembrolizumab (pembro or MK-3475) with or without bevacizumab in patients with recurrent non-curable or metastatic nasopharyngeal carcinoma (NPC).

The study will consist of 2 treatment arms. In Treatment Arm A, patients will be treated with intravenous pembrolizumab alone, 21-day cycle. For Treatment Arm B, patients will receive intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle). Each treatment cycle is 3 weeks. Up to 48 patients will be enrolled in this study in 2 stages. The first stage will consist of 30 patients and the remaining 18 patients will be added if interim data looks promising.

Eligible patients will be randomized 1:1 into either Treatment Arm A or Arm B. Treatment will continue until tumor progression, intolerance to treatment, or up to 2 years (32 doses of pembrolizumab/bevacizumab). For patients who have progressed on pembrolizumab alone, cross over to Arm B is allowed, with repeat biopsy of the lesions before and 1 week after starting bevacizumab. Patients who discontinue from the trial will not be replaced.

The study will collect serial samples of tumor tissue and blood to determine the PD biomarkers of immune activation, in the tumor and systemically, following treatment. This is expected to provide preliminary evidence for immune stimulation using both pembrolizumab and bevacizumab in NPC. The tumor biopsies will also present an opportunity to determine the molecular details of tissue and tumor response to anti-angiogenic therapy.

Eligible patients will be randomized 1:1 into either Treatment Arm A or Arm B. Treatment will continue until tumor progression, intolerance to treatment, or up to 2 years (32 doses of pembrolizumab/bevacizumab). For patients who have progressed on pembrolizumab alone, cross over to Arm B is allowed, with repeat biopsy of the lesions before and 1 week after starting bevacizumab. Patients who discontinue from the trial will not be replaced.

Bevacizumab and Pembrolizumab Combination in EBER-ISH Positive NPC

Phase Ib/II Open-label Study Evaluating the Combination of Bevacizumab Priming With Pembrolizumab in EBER-ISH Positive Nasopharyngeal Carcinoma (NPC)

Comparison of the two treatment arms will be evaluated using the Fisher's exact test. The treatment effect will be quantified via the relative risk estimate and its associated 95% confidence interval (CI).

This will be summarized using the Kaplan-Meier survival estimate for each group. As an exploratory analysis, the log-rank test will be used for comparing differences in PFS, with its effect quantified based on hazard ratio and its 95% CI.

This is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging assessment or death due to any cause, whichever occurs earlier.

Merck Sharp & Dohme LLC

National University Hospital, Singapore

Cytomegalovirus Infections

Cytomegalic Inclusion Disease

Phase I (dose escalation) : An open, single-arm, dose-escalation clinical study to explore the safety, tolerability, and cytodynamic characteristics of CMV and EBV-specific T cells (VSTs), with initial efficacy observations. Subjects enrolled with refractory CMV and/or EBV infection after allogeneic hematopoietic stem cell transplantation were subjected to a 3+3 dose-climb test. Exploring the safety, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of intravenous infusion of multi-virus VSTs.

(2) Phase II (dose expansion) : According to the clinically recommended or safe and effective dose determined by the phase I climb test, the extended study of 1-2 dose groups with 20 cases per dose was performed after joint review by the investigators and project collaborators.

Subjects will receive partial HLA-matched viral-specific T cells (VSTs) against both CMV and EBV on one of the following dose levels:

Level One: 1 x 10\^7 cells/m2 Level Two: 2 x 10\^7cells/m2 Level Three: 5x 10\^7 cellss/m2

Virus specific T cells

Yuanjie Ding

Xuying Pei

Xiangyu Zhao

To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV).

Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.

This study consists of two parts: (1) The first stage is the safety evaluation of multi-virus VSTs and the exploration of DLT and MTD; (2) The second phase is to evaluate the safety and efficacy of multi-viral VSTs in selecting appropriate doses in the first phase.

Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT

An Exploratory Clinical Study of Multivirus-specific T Cells in the Treatment of Refractory Cytomegalovirus and/or Epstein-Barr Virus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, and graft-versus-host-disease will be summarized using descriptive statistics for each dose level

Antiviral efficacy including clinical signs of viral infections, virus reinfection, and laboratory measurement of viral load after VSTs infusion will be determined

Laboratory measurement of virus-specific immune reconstitution before and after VSTs infusion will be tested

Peking University People's Hospital

Professor

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lymphoma

Acquired Immunodeficiency Syndrome

HIV Infections

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Burkitt Lymphoma

Lymphoma, AIDS-Related

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphoma AIDS Related

Lymphoma, Large-cell, Immunoblastic

Antirheumatic Agents

Cyclophosphamide

Prednisone

Rituximab

Vincristine

Pomalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Pomalidomide (escalating doses) + Prednisone, Etoposide, Doxorubicin, Vincristin

Pomalidomide (at the MTD) + Prednisone, Etoposide, Doxorubicin, Vincristine and

0.4 mg/m2/day administered by CIVI on days 1 to 4

60 mg/m2/day administered orally on days 1 to 5

10 mg/m2/day administered by CIVI on days 1 to 4

50 mg/m2/day administered by CIVI on days 1 to 4

An initial dose of 3mg administered orally for 10 days in all cycles. In cycle 1, it will start 5 days before DA-EPOCH; in cycles 2-6, it will start on day 1. Administered at an MTD dose for the expansion phase.

375 mg/m2 administered IV on day 1 (only for CD20+ tumors)

Anaida Widell

Kathryn A Lurain, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating

people with both HIV and NHL.

Objective:

To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.

Eligibility:

Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.

Design:

Participants will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of participant s tumors. In some cases, a new biopsy may be needed.

Participants will receive up to 6 cycles of treatment.

The first cycle is 26 days: Participants will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All participants will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.

The remaining cycles are each 21 days. Participants will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.

Screening tests will be repeated at study visits.

Follow-up visits will continue for 4 years....

Background:

* Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV (PLWH) in the United States. Even in the modern era of antiretroviral therapy (ART), PLWH have an 11- to 17-fold higher risk of NHL than the general population due in part to CD4+ T-cell lymphopenia but also immune dysregulation and exhaustion from chronic viral antigen stimulation.
* The most common NHL subtypes are diffuse large cell lymphoma (DLBCL) and Burkitt lymphoma (BL), that are much more frequently associated with the oncogenic virus Epstein Barr virus (EBV) in PLWH, which portends a poorer prognosis, than in the general population.
* Plasmablastic lymphoma (PBL) is a rare CD20 negative B cell lymphoma associated with EBV almost exclusively seen in PLWH.
* Although these subtypes of lymphoma occur in the general population, their presentation and pathogenesis may be different - meaning there may be different therapeutic targets and strategies to consider in HIV-associated lymphomas necessitating clinical trials targeted to this underserved population of patients.
* Lenalidomide, a 2nd generation immunomodulatory drug, has shown safety and improved survival in combination with chemotherapy in advanced stage DLBCL in one of two randomized trials.
* Pomalidomide, a 3rd generation immunomodulatory agent, has activity in primary CNS lymphoma demonstrating its activity in both NHL and CNS involvement, which is more common in PLWH and NHL. In a number of parameters, it is more potent than lenalidomide.
* Pomalidomide has shown to increase NK and T-cell activation and reverse T-cell senescence in addition to increasing CD4+ T-cell count in PLWH and cancer. It can also enhance expression of

surface immune markers in vitro in cell lines from EBV-induced tumors.

-Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) along with rituximab (DA-EPOCH-R) is an anthracycline-based regimen that has been shown to be safe and effective in PLWH and in the most common subtypes of NHL seen in PLWH, DLBCL and BL.

Objective:

-Determine the safety and maximum tolerated dose (MTD) of the combination of pomalidomide and dose-adjusted EPOCH +/ rituximab (DA-EPOCH-RP) in participants with enrolled subtypes of HIV-associated lymphomas

Eligibility:

* Adult participants \>= 18 years with pathology-confirmed HIV-associated B-cell non-Hodgkin lymphoma with high-risk features, excluding primary CNS lymphoma
* Positive HIV1/2 serology

Design:

-This is a phase 1 study of pomalidomide in combination with DA-EPOCH +/- Rituximab (DA-EPOCH-RP) in participants with HIV-associated B-cell non-Hodgkin lymphoma. Only participants with CD20+ HIV-associated B-cell non-Hodgkin lymphoma will receive

Rituximab.

* This is a dose escalation study to evaluate pomalidomide in combination with modified DA-EPOCH-R to determine safety and tolerability. Dosing will begin at dose level 1, 3 mg of pomalidomide and proceed to dose escalation or de-escalation to doses 4 mg or 2 mg depending on dose-limiting toxicities.
* Participants will be prescribed antiretroviral therapy (ART).
* In this phase I study, up to 12 evaluable participants will be accrued in the escalation phase (3-6 participants per level) and up to 6 evaluable participants will be accrued in the expansion phase to be treated at MTD.

Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

. All IPD recorded in the medical record will be shared with intramural investigators upon request.

The fraction of patients with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.

duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first

Percentage of participants with the best overall response of CR or PR to therapy

National Cancer Institute (NCI)

Adenoviridae Infections

The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.

Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.

Cytotoxic T Lymphocytes

Julie-An Talano, MD

This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.

Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical or mismatched unrelated TCD grafts.

Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV

A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis	NCT02631109	Hemophagocytic ...	Pegaspargase doxorubicin etoposide methylprednisol...	14 Years - 75 Years	Beijing Friendship Hospital
Bevacizumab and Pembrolizumab Combination in EBER-ISH Positive NPC	NCT03813394	Locally Recurre... Metastatic Naso...	pembrolizumab bevacizumab	21 Years - 99 Years	National University Hospital, Singapore
Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT	NCT06075927	CMV Infection EBV Infection Stem Cell Trans...	Virus specific ...	18 Years - 70 Years	Peking University People's Hospital
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas	NCT05389423	Diffuse Large C... Non-Hodgkin Lym... Burkitt Lymphom... Plasmablastic L... B-Cell Neoplasm	Vincristine Prednisone Doxorubicin Etoposide Pomalidomide Cyclophosphamid... Rituximab	18 Years -	National Institutes of Health Clinical Center (CC)
Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV	NCT01535885	Epstein-Barr Vi... Adenovirus Cytomegalovirus...	Cytotoxic T Lym...	- 22 Years	Medical College of Wisconsin

Spots Global Cancer Trial Database for epstein barr virus