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

This study is currently recruiting participants.
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00896493
First received: May 7, 2009
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS.


Condition Intervention Phase
Mycoses
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Bone Marrow Transplant Failure
Lymphoma, Non-Hodgkin
Cutaneous T-cell Lymphoma
Drug: anti-thymocyte globulin
Drug: cyclosporine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin Drug: anti-thymocyte globulin
1.5 mg/kg x 5 days, IV
Other Name: ATG
Drug: cyclosporine
5 mg/kg PO or IV
Other Names:
  • cyclosporine
  • cyclosporin
  • cyclosporin A

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896493

Contacts
Contact: Physician Referrals (650) 723-0822

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Physician Referrals    650-723-0822      
Principal Investigator: Wen-Kai Weng         
Sub-Investigator: Ranjana Hira Advani         
Sub-Investigator: Sally Arai         
Sub-Investigator: Jonathan Benjamin         
Sub-Investigator: Richard T. Hoppe         
Sub-Investigator: Laura A Johnson         
Sub-Investigator: Youn H Kim         
Sub-Investigator: Ginna Laport         
Sub-Investigator: Robert Lowsky         
Sub-Investigator: David Miklos         
Sub-Investigator: Robert S Negrin         
Sub-Investigator: Judith Anne Shizuru         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Wen-Kai Weng Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00896493     History of Changes
Other Study ID Numbers: BMT206, SU-04062009-2138, 16213
Study First Received: May 7, 2009
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Mycoses
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antilymphocyte Serum
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 21, 2014