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

NCT00896493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-05-11

Study results available
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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).

Conditions

  • Mycoses
  • Sezary Syndrome
  • Lymphoma, T-Cell, Cutaneous
  • Bone Marrow Transplant Failure
  • Lymphoma, Non-Hodgkin
  • Cutaneous T-cell Lymphoma

Interventions

DRUG

anti-thymocyte globulin

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

DRUG

cyclosporine

5 mg/kg PO or IV

RADIATION

Lymphoid radiation

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

Sponsors & Collaborators

Principal Investigators

  • Wen-Kai Weng · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2021-11-06
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00896493 on ClinicalTrials.gov