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A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001 | Clinical Trials | Clareo Health

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A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

NCT01196208•Seagen Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Detailed Description

The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
•Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

Exclusion Criteria

•History of another primary malignancy that has not been in remission for at least 3 years
•Known cerebral/meningeal disease
•Peripheral neuropathy of grade 2 or greater
•Females who are pregnant or breastfeeding

Locations (31)

Stanford Cancer Center

Stanford, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

Peter MacCallum Cancer Center

Melbourne, Australia

Leuven University Hospital

Leuven, Belgium

Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

Sofia, Bulgaria

Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

Sofia, Bulgaria

Hopital Saint-Louis/Service d'Hematologie

Paris, Cedex 10, France

South Lyon Hospital Center, Department of Dermatology

Lyon, France

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

Rouen, France

Key Dates

Last Updated

September 21, 2020

Conditions

Disease, HodgkinLymphoma, Large-Cell, AnaplasticLymphoma, Non-HodgkinLymphoma, T-Cell, Cutaneous

Interventions

brentuximab vedotin

DRUG

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

NCT06510361

LymphomaFollicular Lymphoma+2 more

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RECRUITINGPHASE1/PHASE2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT05442515

B-NHLB-Non Hodgkin Lymphoma+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Inclusion Criteria

Exclusion Criteria

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma