Clinical Trials Directory

Trials / Completed

CompletedNCT00896493

Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma

A Phase II Study of Non-myeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) In Patients With Cutaneous T Cell Lymphoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).

Detailed description

Primary Objectives -To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. Secondary Objectives -To evaluate the incidence and extent of acute and chronic graft-versus-host disease (GVHD) and time to engraftment.

Conditions

Interventions

TypeNameDescription
DRUGanti-thymocyte globulinATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg
DRUGcyclosporine5 mg/kg PO or IV
RADIATIONLymphoid radiationTLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1

Timeline

Start date
2009-05-01
Primary completion
2021-11-06
Completion
2022-12-01
First posted
2009-05-11
Last updated
2023-05-11
Results posted
2023-05-11

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT00896493. Inclusion in this directory is not an endorsement.