Trials / Withdrawn

WithdrawnNCT02548468

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

A Two-Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Advanced Cutaneous T Cell Lymphoma

Status: Withdrawn
Phase: Phase 1
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTVES: I. To evaluate regimen related toxicity, engraftment and graft versus host disease (GVHD) in the first 100 days with new reduced intensity haploidentical regimen protocol, including fludarabine (fludarabine phosphate), low dose total body irradiation, and cyclophosphamide. II. To determine an effective donor lymphocyte infusion (DLI) dose that provides successful engraftment without causing GVHD. SECONDARY OBJECTIVES: I. To assess myeloid and lymphoid engraftment rates of patients undergoing treatment on this regimen. II. To determine the incidence and severity of GVHD in patients undergoing treatment on this regimen using a combination of tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis. III. To examine progression free survival and overall survival in patients with cytotoxic T-cell lymphoma (CTCL) undergoing treatment on this regimen. IV. To assess the pace of lymphoid recovery in this patient population. OUTLINE: This is a phase I, dose-escalation study of DLI. REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -11 to -8 and undergo total body irradiation twice daily (BID) on day -7. Patients also receive donor cluster of differentiation (CD)3+ enriched T lymphocyte infusion on day -6 and high-dose cyclophosphamide IV over 2 hours on days -3 to -2. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV with taper (drug wean) by day 60 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. After completion of treatment, patients are followed up periodically.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2015-11-20
Primary completion: 2017-01-23
Completion: 2017-03-16
First posted: 2015-09-14
Last updated: 2025-05-02

Source: ClinicalTrials.gov record NCT02548468. Inclusion in this directory is not an endorsement.