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MycosesPhase 2NCT00896493

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

A Phase 2 study testing anti-thymocyte globulin, cyclosporine and Lymphoid radiation in people with Mycoses and Sezary Syndrome, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
anti-thymocyte globulin, cyclosporine and Lymphoid radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
May 2009to Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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

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).

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

Being tested
anti-thymocyte globulin, cyclosporine, Lymphoid radiation
Medical subject headings
Mycoses, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-thymocyte globulinDrug

    Also called ATG

    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

  • cyclosporineDrug

    Also called cyclosporin, cyclosporin A

    5 mg/kg PO or IV

  • Lymphoid radiationRadiation

    Also called Total lymphoid irradiation (TLI)

    TLI is administered ten times in 80c- 120c Gy fractions on day -11 through day -7 and day -4 through day -1

Study groups in NCT00896493
Study groupRoleWhat they receive
Total lymphoid irradiation & anti-thymocyte immunoglobulinExperimentalTLI 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.
Receives: Drug: anti-thymocyte globulin; Drug: cyclosporine; Radiation: Lymphoid radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) at 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

    Measured: 180 days

Secondary outcomes (8)

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

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

    Measured: 6 months

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

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

    Measured: 2 years

  3. Overall Survival (OS)

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

    Measured: 2 years

  4. Overall Survival (OS)

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

    Measured: 5 years

  5. Mortality

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

    Measured: Up to 5 years

  6. Treatment Related Mortality

    Measured: Up to 5 years

  7. Event Free Survival (EFS)

    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).

    Measured: 2 years

  8. Event Free Survival (EFS)

    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).

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completion6 Nov 2021
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00896493
Sponsor's protocol ID
IRB-16213
Other IDs
SU-04062009-2138, 16213, BMT206
Status last verified
May 2023
First submitted
7 May 2009
Last updated
11 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.

    PubMed 25529383

  • Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.

    PubMed 7581076

  • Weng WK, Arai S, Rezvani A, Johnston L, Lowsky R, Miklos D, Shizuru J, Muffly L, Meyer E, Negrin RS, Wang E, Almazan T, Million L, Khodadoust M, Li S, Hoppe RT, Kim YH. Nonmyeloablative allogeneic transplantation achieves clinical and molecular remission in cutaneous T-cell lymphoma. Blood Adv. 2020 Sep 22;4(18):4474-4482. doi: 10.1182/bloodadvances.2020001627.

    PubMed 32941647

  • Weng WK, Armstrong R, Arai S, Desmarais C, Hoppe R, Kim YH. Minimal residual disease monitoring with high-throughput sequencing of T cell receptors in cutaneous T cell lymphoma. Sci Transl Med. 2013 Dec 4;5(214):214ra171. doi: 10.1126/scitranslmed.3007420.

    PubMed 24307695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin, cyclosporine and Lymphoid radiation in people with Mycoses and Sezary Syndrome, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) at 180 Days (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00896493, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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