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Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Patients With Advanced Cutaneous T Cell Lymphoma

NCT02548468 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-05-02

No results posted yet for this study

Summary

This phase I trial studies the side effects and the best dose of donor lymphocyte infusion when given together with reduced intensity conditioning regimen before partially matched donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor cells and giving them before transplant may stop this from happening. Additionally, giving tacrolimus and mycophenolate mofetil before and after transplant may also stop this from happening.

Conditions

  • Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides and Sezary Syndrome
  • Stage IIB Mycosis Fungoides and Sezary Syndrome
  • Stage IIIA Mycosis Fungoides and Sezary Syndrome
  • Stage IIIB Mycosis Fungoides and Sezary Syndrome
  • Stage IVA Mycosis Fungoides and Sezary Syndrome
  • Stage IVB Mycosis Fungoides and Sezary Syndrome

Interventions

DRUG

Fludarabine

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

BIOLOGICAL

T Cell-Depleted Donor Lymphocyte Infusion

Undergo donor CD3+ enriched T lymphocyte infusion

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSC transplant

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

DRUG

Mycophenolate mofetil

Given IV

DRUG

Tacrolimus

Given IV

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • S. Onder Alpdogan, MD · Thomas Jefferson 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
2015-11-20
Primary Completion
2017-01-23
Completion
2017-03-16

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Drugs

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 NCT02548468 on ClinicalTrials.gov