Phase 2
N=38
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
Mycoses · Sezary Syndrome · Lymphoma, T-Cell, Cutaneous · Bone Marrow Transplant Failure · Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT00896493 ↗Enrolled (actual)
38
Serious AEs
18.4%
Results posted
May 2023
Primary outcome: Primary: Progression-Free Survival (PFS) at 180 Days — 73 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- anti-thymocyte globulin (Drug); cyclosporine (Drug); Lymphoid radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) at 180 Days |
73 | — |
| SECONDARY Number of Participants With Acute Graft-versus-host Disease (GVHD) |
9; 5 | — |
| SECONDARY Number of Participants With Chronic Graft-versus-host Disease (GVHD) |
9 | — |
| SECONDARY Overall Survival (OS) |
56 | — |
| SECONDARY Overall Survival (OS) |
56 | — |
| SECONDARY Mortality |
5; 1; 15 | — |
| SECONDARY Treatment Related Mortality |
1; 1; 1; 1; 1 | — |
| SECONDARY Event Free Survival (EFS) |
26 | — |
| SECONDARY Event Free Survival (EFS) |
26 | — |
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 hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
Eligibility Criteria
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 = 70%.
- Corrected DLCO >= 40%
- Left ventricle ejection fraction (LVEF) > 30%.
- ALT and AST must be = 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 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
Data sourced from ClinicalTrials.gov (NCT00896493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.