CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
anti-thymocyte globulin +2 moredrug
Likely dose
anti-thymocyte globulin 1.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00896493
NCT00896493Phase 2Completed
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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

Stanford University·interventional·Posted May 11, 2009·Updated May 11, 2023

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, cyclosporine, and 1 other intervention for Mycoses and 5 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycoses, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous, Bone Marrow Transplant Failure, Lymphoma, Non-Hodgkin, Cutaneous T-cell Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 6, 2021
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 12.5 yearsPosted 17.1 years ago

Interventions

anti-thymocyte globulindrug

ATG 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

cyclosporinedrug

5 mg/kg PO or IV

Lymphoid radiationradiation

TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1