Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Lymphoma, T-Cell, Cutaneous

Lymphoma, Large-Cell, Anaplastic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, B-Cell

Lymphosarcoma

Hodgkin Lymphoma

B-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

SGN-35T

Seagen Trial Information Support

Youn Kim

Terry-Ann Lynch

Craig Moskowitz

Tatyana Feldman

David Bradfield

Radhakrishnan Ramchandren

Hun Ju Lee, MD

Medical Monitor

This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or types of primary cutaneous lymphoma.

This clinical trial uses a drug called SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time SGN-35T will be used in people. The study drug will be given as an infusion through a vein.

This study will test the safety of SGN-35T in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35T. Part C will use the dose found in parts A and B to find out how safe SGN-35T is and if it works to treat select lymphomas.

This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of SGN-35T in adults with select relapsed/refractory lymphomas. SGN-35T is a CD30-directed antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.

A Safety Study of SGN-35T in Adults With Advanced Cancers

An Open-label Phase 1 Study to Evaluate the Safety of SGN-35T in Adults With Advanced Malignancies

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

To be summarized using descriptive statistics

A subject is determined to have an objective response if, based on disease-specific assessment criteria, they achieve a complete response (CR) or partial response (PR) as assessed by the investigator. The ORR is defined as the percentage of participants with an objective response.

CR rate is defined as the percentage of subjects with CR.

DOR is defined as the time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per disease-specific assessment criteria as assessed by the investigator or to death due to any cause, whichever comes first.

Seagen Inc.

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Leukemia, Plasma Cell

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Plasma Cell Leukemia

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Bortezomib

Dexamethasone acetate

BB 1101

Thalidomide

Interferons

Immunoglobulin A

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment.

Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

Liposome doxorubicin

INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

zhao wang, M.D

zhao wang, Master

Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).

Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria

The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.

Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.

Harbin Hematology and Oncology Institute

Shanghai Changzheng Hospital

Chinese PLA General Hospital

307 Hospital of PLA

Wuhan Union Hospital, China

Beijing Chao Yang Hospital

Henan Provincial People's Hospital

Peking University Third Hospital

Clinical Service, China

Beijing Friendship Hospital

Patients with a diagnosis primary cardiac lymphoma. The study includes patients with PCL diagnosed from 01/01/2000 to 31/12/2020.

Elena Borgo

Samantha Deianira Dattoli

Catello Califano, MD

Claudio Fozza, MD

Elisa Lucchini, MD

Cristina Skert, MD

Giuseppe Gritti, MD

Rosa Daffini, MD

Anna Guidetti, MD

Erika Ravelli, MD

Leonardo Flenghi, MD

Elsa Pennese, MD

Sara Galimberti, MD

Stefan Hohaus, MD

Agostino Tafuri, MD

Anna Marina Liberati, MD

Federica Cavallo, MD

Elisabetta Scarpa, MD

Isacco Ferrarini, MD

The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.

Primary cardiac lymphoma (PCL), an extranodal lymphoma involving only the heart (with possible involvement of the pericardium) is a rare entity, accounting for 2% of primary cardiac tumors and 0.5% of extranodal lymphomas. It is more frequent in males; clinical presentation is predominated by cardiac symptoms. The most common histology is Diffuse Large B Cell Lymphoma (DLBCL). Being DLBCL the most frequent histology, patients are usually treated with R-CHOP (rituximab - cyclophosphamide, doxorubicin, vincristine and prednisone) or R-CHOP-like chemoimmunotherapy regimens, with an historically poor outcome, although in the last years survival rates significantly increased. Due to the rarity of this condition, isolated case reports and a few reviews have been published so far, that in most cases included a population collected in a wide period of time, heterogeneously managed both in terms of treatments received and follow-up, and who often did not strictly respect the criteria of PCL. Indeed, while some aspects of PCL are well-known, especially the ones concerning its clinical presentation, a few topics deserve more in-depth analysis. The rationale of this study is to provide an overview on PCL in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.

In order to perform pathology review, centers are requested to send all the histological and immunohistochemical slides performed at the local site for diagnosis and the block. A possible alternative to the block is 15 unstained slides. Only block and/or only unstained slides availability is not accepted.

Primary Cardiac Lymphoma: Italian Multicenter Experience

Overall survival, the percentage of patients alive of the cohort (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The Complete Remission is defined as the lack of detectable evidence of tumor in the cohort of patients (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The Overall Response Rate is defined as the proportion of patients who have a partial or complete response to therapy (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The Progression-Free Survival is the length of time during and after the treatment that patients live with the disease, but it does not get worse (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The numbers of treatment types and numbers of cycles of therapy received by the cohort of patients (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The numbers of treatment prophylaxis types for Central Nervous System administered to the cohort of patients (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).

The proportion of patients with disease relapse on Central Nervous System (CNS)

Analysis of the following characteristics: Age, gender, disease localization (atria, ventricles, cardiac arteries and veins, pericardium), HIV positivity, type of symptoms at diagnosis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of SGN-35T in Adults With Advanced Cancers	NCT06120504	Lymphoma, T-Cel... Hodgkin Disease Lymphoma, T-Cel... Lymphoma, Large... Lymphoma, Large... Lymphoma, Non-H...	SGN-35T	18 Years -	Seagen Inc.
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia	NCT01328236	Plasma Cell Leu... Multiple Myelom...	Bortezomib Liposome doxoru... Dexamethasone	18 Years - 75 Years	Clinical Service, China
Primary Cardiac Lymphoma: Italian Multicenter Experience	NCT05819528	Primary Cardiac...		18 Years -	Fondazione Italiana Linfomi - ETS
Primary Cardiac Lymphoma: Italian Multicenter Experience	NCT05819528	Primary Cardiac...		18 Years -	Fondazione Italiana Linfomi - ETS
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia	NCT01328236	Plasma Cell Leu... Multiple Myelom...	Bortezomib Liposome doxoru... Dexamethasone	18 Years - 75 Years	Clinical Service, China
A Safety Study of SGN-35T in Adults With Advanced Cancers	NCT06120504	Lymphoma, T-Cel... Hodgkin Disease Lymphoma, T-Cel... Lymphoma, Large... Lymphoma, Large... Lymphoma, Non-H...	SGN-35T	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for pcl

Every month we try and update this database with for pcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pcl

Every month we try and update this database with for pcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.