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Lymphoma, Large-Cell, Anaplastic clinical trials

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NCT ID: NCT03942263 Completed - Hodgkin Disease Clinical Trials

A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation

KLIO
Start date: May 31, 2019
Phase:
Study type: Observational

The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

NCT ID: NCT03905135 Completed - Clinical trials for Anaplastic Large Cell Lymphoma

Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies

Start date: June 7, 2019
Phase: Phase 1
Study type: Interventional

Background: Some T-cell lymphomas and leukemias do not respond to standard treatment. Researchers hope to develop a treatment that works better than current treatments. Objective: To test if interleukin (IL-5) combined with avelumab is safe and effective for treating certain cancers. Eligibility: People ages 18 and older with relapsed T-cell leukemias and lymphomas for which no standard treatment exists or standard treatment has failed Design: Participants will be screened with: - Medical history - Physical exam - Blood, urine, heart, and lung tests - Possible tumor biopsy - Bone marrow biopsy: A small needle will be inserted into the hipbone to take out a small amount of marrow. - Computed tomography (CT) or positron emission tomography (PET) scans and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body. Participants will get the study drugs for 6 cycles of 28 days each. They will have a midline catheter inserted: A tube will be inserted into a vein in the upper chest. They will get Interleukin-15 (IL-5) as a constant infusion over the first 5 days of every cycle. They will get avelumab on days 8 and 22 of each cycle. They will be hospitalized for the first week of the first cycle. Participants will have tests throughout the study: - Blood and urine tests - Another tumor biopsy if their disease gets worse - Scans every 8 weeks - Possible repeat MRI - Another bone marrow biopsy at the end of treatment, if there was lymphoma in the bone marrow before treatment, and they responded to treatment everywhere else. After they finish treatment, participants will have visits every 60 days for the first 6 months. Then visits will be every 90 days for 2 years, and then every 6 months for 2 years. Visits will include blood tests and may include scans.

NCT ID: NCT03766516 Completed - Clinical trials for Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma

Registry of BrentuximabVedotinin Patients With R/R Anaplastic Large Cell Lymphoma or Classical HL

BRAVO
Start date: November 1, 2018
Phase:
Study type: Observational [Patient Registry]

In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected. Recently, there has been a report of successful stem cell transplantation with full response to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role as a bridge therapy before stem cell transplantation has also been suggested. Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type. Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients. Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients. It shows consistent response to anti-CD30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive in the recent phase-2 study. As Korea currently lacks real-world evidence in relation to BV, this study was conducted to address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.

NCT ID: NCT03603847 Completed - Clinical trials for Anaplastic Large Cell Lymphoma, ALK-Positive

Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

Start date: August 2, 2018
Phase:
Study type: Observational

The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS). - at diagnosis - after the first cycle of CHOEP (early evaluation) - at the end of treatment

NCT ID: NCT03534180 Completed - Clinical trials for Anaplastic Large Cell Lymphoma

Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma

Start date: August 21, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and best dose of venetoclax and romidepsin to see how well it works in treating patients with mature T-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03493451 Completed - Clinical trials for Anaplastic Large Cell Lymphoma

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Start date: April 13, 2018
Phase: Phase 2
Study type: Interventional

This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: - Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) - Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) - Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

NCT ID: NCT03397953 Completed - Clinical trials for Anaplastic Large Cell Lymphoma

Vinorelbine for Recurrent ACLC

Start date: November 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

NCT ID: NCT03049449 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas

Start date: March 17, 2017
Phase: Phase 1
Study type: Interventional

Background: - Improved treatments for a variety of treatment-resistant, TNFRSF8 (CD30)-expressing malignancies including Hodgkin lymphoma, anaplastic large cell lymphoma, and other CD30- expressing lymphomas are needed. - T cells can be genetically modified to express chimeric antigen receptors (CARs) that specifically target malignancy-associated antigens. - Autologous T cells genetically modified to express CARs targeting the B-cell antigen B-lymphocyte antigen CD19 (CD19) have caused complete remissions in a small number of patients with lymphoma. These results demonstrate that CAR-expressing T cells can have anti-lymphoma activity in humans. - CD30 expression can be easily detected by immunohistochemistry on lymphoma cells, which allows selection of CD30-expressing malignancies for treatment. - CD30 is not known to be expressed by normal cells except for a small number of activated lymphocytes. - We have constructed a novel fully-human anti-CD30 CAR that can specifically recognize CD30-expressing target cells in vitro and eradicate CD30-expressing tumors in mice. - This particular CAR has not been tested before in humans. - Possible toxicities include cytokine-associated toxicities such as fever, hypotension, and neurological toxicities. Elimination of a small number of normal activated lymphocytes is possible, and unknown toxicities are also possible. Objectives: Primary -Determine the safety and feasibility of administering T-cells expressing a novel fully human anti-CD30 CAR to patients with advanced CD30-expressing lymphomas. Eligibility: - Patients must have anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, grey zone lymphoma, enteropathy associated T-cell lymphoma, or extranodal natural killer (NK)/T-cell lymphoma, nasal type - Patients must have malignancy that is both measurable on a computed tomography (CT) scan with a largest diameter of at least 1.5 cm and possessing increased metabolic activity detectable by positron emission tomography (PET) scan. Alternatively, patients with lymphoma detected by flow cytometry of bone marrow are eligible. - Patients must have a creatinine of 1.6 mg/dL or less and a normal cardiac ejection fraction. - An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 is required. - No active infections are allowed including evidence of active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. At the time of protocol enrollment patients must be seronegative for cytomegalovirus (CMV) by antibody testing or must have a negative blood CMV polymerase chain reaction (PCR). - Absolute neutrophil count greater than or equal to 1000/micro L, platelet count greater than or equal to 55,000/micro L, hemoglobin greater than or equal to 8g/dL - Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less or equal to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. - At least 14 days must elapse between the time of any prior systemic treatment (including corticosteroids above 5 mg/day of prednisone or equivalent corticosteroid dose) and initiation of required leukapheresis. - Clear CD30 expression must be detected on 75% or more of malignant cells from either bone marrow or lymphoma mass by flow cytometry or immunohistochemistry. The patient s malignancy will need to be assessed for CD30 expression by flow cytometry or immunohistochemistry performed at the National Institutes of Health (NIH). If unstained, paraffin-embedded bone marrow or lymphoma sections are available from prior biopsies, these can be used to determine CD30 expression by immunohistochemistry; otherwise, patients will need to come to the NIH for a biopsy to determine CD30 expression. The sample for CD30 expression can come from a biopsy obtained at any time before enrollment, unless the patient has received a prior anti-CD30 monoclonal antibody, in which case the sample must come from a biopsy following completion of the most recent anti-CD30 monoclonal antibody treatment. - Eligible patients with diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma must have received 2 prior treatment regimens at least 1 of which included an anthracycline and an anti-CD20 monoclonal antibody. - Patients who have never had an allogeneic hematopoietic stem cell transplant as well as patients who have had a 9/10 or 10/10 human leukocyte antigen (HLA)-matched sibling or a 9/10 or 10/10 HLA- matched unrelated donor hematopoietic stem cell transplant are potentially eligible. - Women who are pregnant or plan to become pregnant will be excluded.

NCT ID: NCT03040206 Completed - Clinical trials for Angioimmunoblastic T-cell Lymphoma

Risk Stratification of Nodal PTCL

Start date: January 2017
Phase:
Study type: Observational

This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.

NCT ID: NCT02939014 Completed - Hodgkin Disease Clinical Trials

Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

Start date: November 7, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).