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

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ClinicalTrials.gov Identifier: NCT00896493
Recruitment Status : Recruiting
First Posted : May 11, 2009
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease Intervention/treatment 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 Radiation: Lymphoid radiation Phase 2

Detailed Description:

Primary Objectives

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

Secondary Objectives

-To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin
TLI is administered from a 6 MeV linear accelerator in 80c- 120c Gy fractions. Anti-thymocyte-Globulin (ATG) is administered intravenously for a total dose of 7.5 mg/kg.
Drug: anti-thymocyte globulin
ATG will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg
Other Name: ATG

Drug: cyclosporine
5 mg/kg PO or IV
Other Names:
  • cyclosporin
  • cyclosporin A

Radiation: Lymphoid radiation
TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1
Other Name: Total lymphoid irradiation (TLI)




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) at 180 days [ Time Frame: 180 days ]
    Progression-Free Survival (PFS) will be assessed at 180 days


Secondary Outcome Measures :
  1. 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 ]
  2. Overall Survival (OS) [ Time Frame: 2 years ]
  3. Treatment related mortality [ Time Frame: 2 years ]
  4. Event Free survival (EFS) [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.
  2. Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
  3. Age > 18 years and <= 75 years.
  4. Karnofsky Performance Status >= 70%.
  5. Corrected DLCO >= 40%
  6. Left ventricle ejection fraction (LVEF) > 30%.
  7. ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease.
  8. Estimated creatinine clearance >= 50 ml/min.
  9. Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.
  10. Signed informed consent.
  11. Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible.
  12. Patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible.

Donor Inclusion Criteria

  1. Age >=17.
  2. HIV seronegative.
  3. No contraindication to the administration of G-CSF.
  4. Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate

Exclusion Criteria:

  1. Uncontrolled active infection.
  2. Uncontrolled congestive heart failure or angina.
  3. Pregnancy or nursing patients will be excluded from the study.
  4. Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.

Donor Exclusion Criteria

  1. Serious medical or psychological illness.
  2. Pregnant or lactating women are not eligible
  3. Prior malignancies within the last 5 years except for non-melanoma skin cancers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896493


Contacts
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Contact: Michelle Chin 650-721-4183 mchin88@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Michelle Chin    650-721-4183    mchin88@stanford.edu   
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: Robert Lowsky         
Sub-Investigator: David Miklos         
Sub-Investigator: Robert S Negrin         
Sub-Investigator: Judith Anne Shizuru         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Wen-Kai Weng Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00896493     History of Changes
Other Study ID Numbers: BMT206
SU-04062009-2138 ( Other Identifier: Stanford University )
16213 ( Other Identifier: Stanford IRB )
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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