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Immunosuppressant

anti-thymocyte globulin for Fungal Infection

Phase 2

Waitlist Available

Led By Wen-Kai Weng

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will use a non-myeloablative approach to allogeneic transplantation to treat patients with advanced MF/SS. This is a reasonable option given the median age at diagnosis and the increased risk of infection for these patients.

Eligible Conditions

Fungal Infection
Sezary Syndrome
Cutaneous T-Cell Lymphoma
Bone Marrow Transplant
Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS) at 180 Days

Secondary outcome measures

Event Free Survival (EFS)

Mortality

Number of Participants With Acute Graft-versus-host Disease (GVHD)

+3 more

Side effects data

From 2019 Phase 2 & 3 trial • 361 Patients • NCT00003816

45%

acute graft-versus-host disease

20%

1 yr TRM

100%

80%

60%

40%

20%

Study treatment Arm

BuCy

FluMel

Other

VpCyTBI

CyTBI

Trial Design

1Treatment groups

Experimental Treatment

Group I: Total lymphoid irradiation & anti-thymocyte immunoglobulinExperimental Treatment3 Interventions

TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

anti-thymocyte globulin

2005

Completed Phase 3

~1000

cyclosporine

2000

Completed Phase 3

~1290

Lymphoid radiation

2009

Completed Phase 2

~40

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,312 Total Patients Enrolled

Wen-Kai WengPrincipal InvestigatorStanford University

5 Previous Clinical Trials

597 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there precedent clinical trials that have utilized anti-thymocyte globulin?

"At the moment, 71 clinical trials worldwide are investigating anti-thymocyte globulin. 13 of those active studies are in Phase 3. Even though most trials for anti-thymocyte globulin take place in Assiut, there are a total of 475 research sites running these investigations."

Answered by AI

Are there any risks associated with using anti-thymocyte globulin?

"While Phase 2 trials don't have much data to support efficacy, anti-thymocyte globulin received a safety score of 2."

Answered by AI

How many people can join this clinical trial at the most?

"This study is not admitting any more patients at the moment. This particular trial was first posted on May 1st, 2009 and updated as recently as June 16th, 2022. If you are interested in other similar studies, there are 1837 trials for granulomatous slack skin and 71 trials for anti-thymocyte globulin currently looking for participants."

Answered by AI

Besides its primary function, what are other potential benefits to anti-thymocyte globulin?

"anti-thymocyte globulin is a medication used to help patients who are receiving transplants and those suffering from conditions like lupus nephritis, bulla, or excessive tearing."

Answered by AI

Can new patients still join this clinical trial?

"Based on the information available, it appears that this particular study is not recruiting patients at this time. Although, there are 1908 other trials which may be of interest and are actively looking for participants."

Answered by AI

Recent research and studies

Science Translational MedicineJournal

Minimal Residual Disease Monitoring with High-throughput Sequencing of T Cell Receptors in Cutaneous T Cell Lymphoma

Weng, Wen-Kai, Randall Armstrong, Sally Arai, Cindy Desmarais, Richard Hoppe, and Youn H. Kim. 2013. “Minimal Residual Disease Monitoring with High-throughput Sequencing of T Cell Receptors in Cutaneous T Cell Lymphoma”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3007420.

Blood AdvancesJournal

Nonmyeloablative Allogeneic Transplantation Achieves Clinical and Molecular Remission in Cutaneous T-cell Lymphoma

Weng, Wen-Kai, Sally Arai, Andrew Rezvani, Laura Johnston, Robert Lowsky, David Miklos, Judith Shizuru, et al.. 2020. “Nonmyeloablative Allogeneic Transplantation Achieves Clinical and Molecular Remission in Cutaneous T-cell Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020001627.

Biology of Blood and Marrow TransplantationJournal

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host Disease: I. The 2014 Diagnosis and Staging Working Group Report

Jagasia, Madan H., Hildegard T. Greinix, Mukta Arora, Kirsten M. Williams, Daniel Wolff, Edward W. Cowen, Jeanne Palmer, et al.. 2015. “National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host Disease: I. The 2014 Diagnosis and Staging Working Group Report”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2014.12.001.

clinicaltrials.govStudy