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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mycoses, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous, Bone Marrow Transplant Failure, Lymphoma, Non-Hodgkin, Cutaneous T-cell Lymphoma

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Trial Information

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


Inclusion Criteria:



3.1 Inclusion Criteria

3.1.1 Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1
standard systemic therapy or are not candidates for standard therapy.

3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical
Center.

3.1.4 Age > 18 years and <= 75 years.

3.1.5 Karnofsky Performance Status >= 70%.

3.1.6 Corrected DLCO >= 40%

3.1.7 Left ventricle ejection fraction (LVEF) > 30%.

3.1.8 ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or
Gilbert's disease.

3.1.9 Estimated creatinine clearance >= 50 ml/min.

3.1.10 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in
HLA-A, B, C or DRB1.

3.1.11 Signed informed consent.

3.3 Donor Inclusion Criteria

3.3.1 Age >=17.

3.3.2 HIV seronegative.

3.3.3 Signed informed consent.

3.3.4 No contraindication to the administration of G-CSF.

3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins
are inadequate.

3.5 Enrollment

Enrollment occurs when all eligibility criteria are met.

Exclusion Criteria:

3.2 Exclusion Criteria

3.2.1 Uncontrolled active infection.

3.2.2 Uncontrolled congestive heart failure or angina.

3.2.3 Pregnancy or nursing patients will be excluded from the study.

3.2.4 Those who are HIV-positive will be excluded from the study due to high risk of
lethal infection after hematopoietic cell transplantation.

3.2.5 No prior malignancy is allowed except adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer or other cancer for which the patients has been
disease-free for five years.

3.4 Donor Exclusion Criteria

3.4.1 Serious medical or psychological illness.

3.4.2 Pregnant or lactating women are not eligible

3.4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Wen-Kai Weng

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT206

NCT ID:

NCT00896493

Start Date:

May 2009

Completion Date:

December 2022

Related Keywords:

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

Name

Location

Stanford University School of MedicineStanford, California  94305-5317