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

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00896493
Collaborator
(none)
36
1
1
163
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Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
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 1, 2009
Actual Primary Completion Date :
Nov 6, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Total lymphoid irradiation (TLI)
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) at 180 days [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. [acute-first 100 days after transplant chronic-from 100days year]

    2. Overall Survival (OS) [2 years]

      Overall survival (OS) is the time measurement between the day of allogeneic transplant and death from any cause.

    3. Treatment related mortality [2 years]

      Total count of treatment related mortality will be reported.

    4. Event Free survival (EFS) [2 years]

      Event-free survival (EFS) is the time measurement between the day of allogeneic transplant and the first documented recurrence or death from any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Wen-Kai Weng, Stanford University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT00896493
    Other Study ID Numbers:
    • IRB-16213
    • SU-04062009-2138
    • 16213
    • BMT206
    First Posted:
    May 11, 2009
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Jun 21, 2022