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.

Doxorubicin

Liposomal doxorubicin

Study on the use of a polychemotherapy scheme based on liposomal doxorubicin, vinblastine and dacarbazine (MVD) as first line in the therapy of elderly patients affected by classic Hodgkin lymphoma

Classic Hodgkin lymphoma (c-HL) is a neoplasm that originates from B lymphocytes and represents 10% of all lymphomas. The most affected age group is between 20 and 30 years of age, with a second peak in the epidemiological distribution involving patients over 60 years of age.

Elderly patients often present with already advanced disease stages and B symptoms. On the other hand, these patients often have multiple comorbidities and reduced fitness and this can limit the therapeutic possibilities with curative intent in terms of doses and adherence to the timing foreseen by the therapeutic protocol.

The optimal therapy for this category of patients is not yet well defined. In fact, the prognosis of these patients is typically poor.

The ABVD regimen (doxorubicin, i.e. Adriamycin, Bleomycin, Vinblastine, Dacarbazine) is a therapeutic option for elderly/unfit patients but is associated with considerable toxicity and mortality. In particular, mortality rates due to lung damage from Bleomycin are between 4-24% and mortality rates due to cardiac damage are reported in elderly patients suffering from c-HL and treated with regimens based on anthracyclines (of which doxorubicin belongs part) which fluctuate between 6 and 15%.

Non-pegylated liposomal anthracycline (NPLD) was initially used in patients with breast cancer and this particular formulation spares tissues characterized by tight capillary junctions (such as cardiac muscle tissue) from the direct cytotoxic effect of doxorubicin.

Regimens based on NPLD associated with bleomycin, vinblastine and dacarbazine have been studied for the first-line treatment of cardiac patients with c-HL and NPLD has been shown to accumulate in macrophages associated with tumor tissue, as well as in the spleen, liver, lung and bones that act as long-release reservoirs with a likely prolonged therapeutic effect.

The aim of the present project is to investigate the front-line use of the MVD polychemotherapeutic regimen (NPLD, Bleomycin and Dacarbazine) for elderly patients suffering from c-HL in terms of Overall Survival, Progression-Free Survival, FDG-PET/CT negativity rate at the end of therapy, toxicity and feasibility.

This was a retrospective, single-center study conducted in the Hematology Unit of the Federico II University of Naples (Italy), in which patients aged ≥60 years with previously untreated, biopsy-proven c-HL were identified in the database of the Hematology Unit of the Federico II University from 1 January 2013 to 1 January 2023. All necessary approvals were obtained from our ethics committee. The study was undertaken in accordance with the Declaration of Helsinki. All patients provided written informed consent for data analysis.

The primary objective of the study was to evaluate whether the front-line therapy without bleomycin by using NPLD-containing regimen, i.e., Myocet TM with its pharmacokinetic and pharmacodynamic advantages in terms of efficacy and safety, could improve OS in older adults with c-HL with extensive disease. Other objectives were PFS, EoT overall response rate by using FDG-PET scans interpreted with the Deauville scale (DS) 5-point scoring system (according to the Lugano Classification) , hematologic and extra-hematologic toxicity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), and feasibility (arbitrarily defined as ≤5 patients receiving \<85% of the planned dose). Noteworthy, the cardiologic toxicity profile was established by using the echocardiography assessment of global systolic longitudinal myocardial strain (GLS), as well as left ventricular ejection fraction (LVEF) (according to the guidelines of the Task Force for Cancer Treatments and Cardiovascular Toxicity of the European Society of Cardiology \[ESC\]).

The schedule of study treatment is shown in detail in Table 1. The dosage of Myocet TM in the MVD scheme was well within the ceiling dose of 785 mg/m 2 (the median lifetime dose reported for NPLD at the onset of cardiotoxicity). Patients were scheduled to receive six cycles of therapy with MVD which consisted of 1-day outpatient i.v. infusions of Myocet TM at a dose of 25 mg/m 2 , plus vinblastine 6 mg/m 2 , and dacarbazine 375 mg/m 2 on days 1 and 14 of each course every 28 days, for twelve administrations. Planned cumulative dose-intensity of NPLD was 300 mg/m 2.

For those cases with initial large nodal mass (defined as systemic adenopathy with the largest diameter \>5 cm), consolidation radiotherapy (c-RT) at 30 Gy was given (after EoT PET assessments), following the scheduled 6 MVD cycles, on residual bulky area, that is, containing post-chemotherapy FDG-PET negative nodes of size ≥2.0 cm at CT scans as already reported.

FDG-PET examinations were conducted at staging, EoT and thereafter every 3-6 months. FDG-PET results were reported according to the DS score using visual assessment followed by quantitative verification as already described. Negative FDG-PET scans were defined as DS ≤3 score, and positive FDG-PET scans were defined as DS 4 and 5 scores (Supplemental data, FDG- PET assessments). All patients were scheduled to undergo a full cardiologic examination, 2D echocardiography, and speckle tracking echocardiography (STE) at baseline, interim, EoT and within six months from the end of all antineoplastic treatments.

Clinical cardiologist experts in echocardiography analyzed each study for standard echocardiography and strain measurements.

Physical examination and bone marrow biopsy were also performed at baseline, and then at physician's discretion. Routine blood laboratory test monitoring was performed before every cycle of chemotherapy, for each patient.

OS was defined as the time from the date of HL diagnosis to the date of last follow-up or death for any cause. PFS was defined as the time from day 1 of MVD ﬁrst dose to disease progression/relapse (event), death from any cause (event) or last follow-up visit (censoring). All efficacy and safety evaluations were performed in patients who received at least one course of MVD. Patients' characteristics, response rate, toxicity and safety data were reported descriptively as number and percentage, or as median and range. Survival curves were estimated by the Kaplan-Meier method. Cox regression analysis was used to estimate the hazard ratio (HR) and the 95% confidence interval (CI) for the treatment effect on OS and PFS. The evaluated factors included age stratification (years: 60-69 vs. 70-79 vs. ≥80), B symptoms, large nodal mass, nodal and/or extra-nodal sites involved, stage IV, and international prognostic score (IPS) risk group at baseline. Differences between groups were tested by the log-rank test, and student-T test. The P value for statistical significance was set at 0.05 for all evaluations. Statistical analysis was performed using R software (version 4.1).

Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With HL (HL-MVD)

Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With Classic Hodgkin Lymphoma: a Multicenter Phase II Study

The primary endpoint was the activity of the liposomal doxorubicin-based front-line strategy in terms of OS.

end-of-treatment (EoT) 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography (FDG-PET)-negativity

hematological and cardiac grade \>3 adverse events

Federico II University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Melanoma, Cutaneous Malignant

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Skin Diseases

Breast Diseases

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Ovarian Cancer

Diffuse Large B-Cell Lymphoma

Stomach Cancer

Ovarian Epithelial Cancer

Peripheral T-cell Lymphoma

Given into the vein (IV; intravenously) on Day 1 of each 21-day cycle

SEA-TGT

Given via injection under the skin (subcutaneous) on Day 1 of each 21-day cycle

sasanlimab

Given by IV on Day 1 of each 21-day cycle

brentuximab vedotin

Andres Forero-Torres, MD

This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.

The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).

A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer

A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria

Proportion of participants with CR per the participant's specific tumor response criteria

Time from first response to the first documentation of disease progression or death due to any cause

Time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first

Time from first dose to the first documentation of disease progression or death due to any cause

Time from start of study treatment to the date of death due to any cause

To be summarized using descriptive statistics.

Antirheumatic Agents

Rituximab

Brentuximab vedotin:

Will be administered at 1.8 mg/kg IV over 30 minutes is given for up to 10 doses (cycles), with a cycle length of 21 days. Brentuximab vedotin is first given on day 1 of cycles 1, 2, 3, and 4 as a single agent (weeks 0, 3, 6, and 9, respectively). Four cycles are chosen because of the 12-week median time to CR in the pivotal phase 2 trial of brentuximab vedotin after autologous BMT for HL.

Brentuximab vedotin will be administered with Rituximab at 375 mg/m2 IV is given for up to 8 "induction" doses: day 1 of week 6, 7, 8, and 9; day 1 of week 12, 15, 18 and 21. This is followed by rituximab "maintenance" (375 mg/m2 IV once every 3 months x 2 doses) to complete a \~ 1 year total course of therapy.

Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.

Brentuximab vedotin

Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.

Nina Wagner-Johnston, MD

This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).

This research is being done to study a combination of drugs for relapsed Hodgkin's Lymphoma (HL) that may be easier to tolerate than standard therapies and that does not involve an autologous blood or marrow transplant (BMT, also called a stem cell transplant).The study is for people with HL who have never received treatment for relapsed lymphoma, except for radiation therapy. Usually, when HL relapses for the first time, the standard is to receive combinations of chemotherapy, including an autologous blood or marrow transplant (BMT, also called a stem cell transplant) which has about a 40% cure rate. BMT may cure the HL, but also may be associated with serious side effects and risks. This research looks at a combination of drugs for relapsed HL that may not have the side effects of standard therapies and that does not involve BMT. The goal is to treat the lymphoma effectively with drugs that we expect will have fewer side effects, while avoiding a treatment like BMT.

Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

Pilot Study of Rituximab and Brentuximab Vedotin With Deferred BMT for Relapsed Classical Hodgkin Lymphoma

Percentage of participants alive without any of the following: death, disease progression or relapse, or failure to achieve complete remission as defined by the Cheson criteria. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir

Percentage of participants with grade 3-4 adverse events by CTCAE 4.0.

Percentage of participants alive with and without disease relapse.

Percentage of participants with partial and complete remissions as defined by Cheson criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions

Median number of weeks from protocol initiation to best response.

Median number of weeks that best response was maintained until disease relapse or death.

Median percentage change in CCBCs between initiation and completion of study.

Genentech, Inc.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Anti-Infective Agents

Etoposide

Cytarabine

Pembrolizumab

Melphalan

Etoposide phosphate

Carmustine

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.

Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion.

Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year.

On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

Autologous stem cell transplant

Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.

Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.

Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.

Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning.

Sanjal Desai

Roberta Nicklow

This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.

MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma

Number of participants with progression free survival at 1 year post transplant.

Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.

Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.

Number of participants experiencing death without relapse.

Participants experiencing complete response at day 28 post-ASCT.

Masonic Cancer Center, University of Minnesota

Symptoms and General Pathology

Recurrence

Nivolumab

Fludarabine

Fludarabine phosphate

Bendamustine Hydrochloride

Study treatment will include 4 cycles of nivolumab and a single CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy of Fludarabine and Bendamustine).

Autologous CD30.CAR-T

Bendamustine

Helen Heslop, MD

Sairah Ahmed, MD

This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Upon successful leukapheresis to produce CD30.CAR-T cells, patients will enter the treatment phase of the study. Treatments will include 4 cycles of nivolumab and CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy). Patients will then enter the post-treatment follow-up phase of the study, whereby patients will undergo either autologous stem cell transplant or continue to receive up to 6 additional treatment cycles of nivolumab. Patients will be followed for response assessments and safety monitoring until end of study (EOS); approximately 3 years after leukapheresis. Long-term follow-up will continue with additional safety monitoring and survival for up to 15 years after Leukapheresis.

Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

Phase 1b Study Evaluating the Safety and Efficacy of Autologous CD30.CAR-T in Combination With PD-1 Checkpoint Inhibitor (Nivolumab) in Relapsed or Refractory Classical Hodgkin Lymphoma Patients After Failure of Frontline Therapy (ACTION)

Time to peak concentration of CD30.CAR-T in the blood

Area under the curve of CD30.CAR-T in the blood

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.
Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With HL (HL-MVD)	NCT06235047	Classic Hodgkin...		60 Years -	Federico II University
A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer	NCT04254107	Non-small Cell ... Gastric Carcino... Gastroesophagea... Classical Hodgk... Diffuse Large B... Peripheral T-ce... Cutaneous Melan... Head and Neck S... Bladder Cancer Ovarian Cancer Triple Negative... Cervical Cancer	SEA-TGT sasanlimab brentuximab ved...	18 Years -	Seagen Inc.
Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma	NCT01900496	Lymphoma	Brentuximab ved... Rituximab	16 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma	NCT01900496	Lymphoma	Brentuximab ved... Rituximab	16 Years - 100 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma	NCT06377540	Autologous Stem... Classic Hodgkin...	Pembrolizumab Autologous stem... Carmustine Etoposide Cytarabine Melphalan	18 Years -	Masonic Cancer Center, University of Minnesota
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma	NCT06377540	Autologous Stem... Classic Hodgkin...	Pembrolizumab Autologous stem... Carmustine Etoposide Cytarabine Melphalan	18 Years -	Masonic Cancer Center, University of Minnesota
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy	NCT05352828	Classical Hodgk... Hodgkin Disease... Hodgkin Disease...	Nivolumab Autologous CD30... Fludarabine Bendamustine	12 Years -	Tessa Therapeutics
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy	NCT05352828	Classical Hodgk... Hodgkin Disease... Hodgkin Disease...	Nivolumab Autologous CD30... Fludarabine Bendamustine	12 Years -	Tessa Therapeutics
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 chl

Every month we try and update this database with for chl 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 chl

Every month we try and update this database with for chl 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 chl 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.