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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT00896493
• Date of registration: 07/05/2009
• Primary sponsor: Stanford University
• Public title: Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
• Scientific title: 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
• Date of first enrolment: May 2009
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00896493
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: BMT Referrals

• Name: BMT Referrals

• Name: Wen-Kai Weng
• Affiliation: Stanford University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bone Marrow Transplant Failure

Cutaneous T-cell Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, T-Cell, Cutaneous

Mycoses

Sezary Syndrome

Intervention(s)

Drug: anti-thymocyte globulin

Drug: cyclosporine

Primary Outcome(s)

To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [Time Frame: 2 years]

Secondary Outcome(s)

To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment. [Time Frame: acute-first 100 days after transplant chronic-from 100days year]

Secondary ID(s)

16213

BMT206

SU-04062009-2138

Source(s) of Monetary Support

Please refer to primary and secondary sponsors