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Completed

NCT Number: NCT00896493

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

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 hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).

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Key information

About this study

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 graft-versus-host disease (GVHD) and time to engraftment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.
  • Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
  • Age > 18 years and <= 75 years.
  • Karnofsky Performance Status >= 70%.
  • Corrected DLCO >= 40%
  • Left ventricle ejection fraction (LVEF) > 30%.
  • ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease.
  • Estimated creatinine clearance >= 50 ml/min.
  • Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.
  • Signed informed consent.
  • Patients with prior malignancies diagnosed > 5 years ago without evidence of disease are eligible.
  • 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

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

Exclusion criteria

  • Uncontrolled active infection.
  • Uncontrolled congestive heart failure or angina.
  • Pregnancy or nursing patients will be excluded from the study.
  • 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

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

Treatment and study plan

anti-thymocyte globulin

Drug

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

cyclosporine

Drug

5 mg/kg PO or IV

Other names: cyclosporin, cyclosporin A

Lymphoid radiation

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)

Primary outcomes

  1. Progression-Free Survival (PFS) at 180 Days

    Time frame: 180 days

    Progression-Free Survival (PFS; time to disease progression or death from any cause) assessed at 180 days (Kaplan-Meier estimate). Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary outcomes

  1. Number of Participants With Acute Graft-versus-host Disease (GVHD)

    Time frame: 6 months

    Cumulative incidence at 6 months. GvHD was assessed using the 2015 NIH consensus criteria.

  2. Number of Participants With Chronic Graft-versus-host Disease (GVHD)

    Time frame: 2 years

    Cumulative incidence at 6 months (any grade). GvHD was assessed using the 2015 NIH consensus criteria.

  3. Overall Survival (OS)

    Time frame: 2 years

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

  4. Overall Survival (OS)

    Time frame: 5 years

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

  5. Mortality

    Time frame: Up to 5 years

    Total count of non-relapsed mortality and mortality from relapsed disease.

  6. Treatment Related Mortality

    Time frame: Up to 5 years

  7. Event Free Survival (EFS)

    Time frame: 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 (Kaplan-Meier estimate).

  8. Event Free Survival (EFS)

    Time frame: 5 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 (Kaplan-Meier estimate).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2021
Study completion
2022
First posted
May 11, 2009
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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