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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00896493
First received: May 7, 2009
Last updated: February 12, 2014
Last verified: February 2014

May 7, 2009
February 12, 2014
May 2009
December 2022   (final data collection date for primary outcome measure)
To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival.
Complete list of historical versions of study NCT00896493 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
To evaluate the incidence and extent of acute and chronic GVHD and time to engraftment.
Not Provided
Not Provided
 
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
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 HSCT using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced MF/SS.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mycoses
  • Sezary Syndrome
  • Lymphoma, T-Cell, Cutaneous
  • Bone Marrow Transplant Failure
  • Lymphoma, Non-Hodgkin
  • Cutaneous T-cell Lymphoma
  • Drug: anti-thymocyte globulin
    1.5 mg/kg x 5 days, IV
    Other Name: ATG
  • Drug: cyclosporine
    5 mg/kg PO or IV
    Other Names:
    • cyclosporine
    • cyclosporin
    • cyclosporin A
Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin
Interventions:
  • Drug: anti-thymocyte globulin
  • Drug: cyclosporine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2022
December 2022   (final data collection date for primary outcome measure)

Inclusion Criteria:

3.1 Inclusion Criteria

3.1.1 Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy.

3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

3.1.4 Age > 18 years and <= 75 years.

3.1.5 Karnofsky Performance Status >= 70%.

3.1.6 Corrected DLCO >= 40%

3.1.7 Left ventricle ejection fraction (LVEF) > 30%.

3.1.8 ALT and AST must be <= 3X normal. Total bilirubin <= 3 mg/dL unless hemolysis or Gilbert's disease.

3.1.9 Estimated creatinine clearance >= 50 ml/min.

3.1.10 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1.

3.1.11 Signed informed consent.

3.3 Donor Inclusion Criteria

3.3.1 Age >=17.

3.3.2 HIV seronegative.

3.3.3 Signed informed consent.

3.3.4 No contraindication to the administration of G-CSF.

3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate.

3.5 Enrollment

Enrollment occurs when all eligibility criteria are met.

Exclusion Criteria:

3.2 Exclusion Criteria

3.2.1 Uncontrolled active infection.

3.2.2 Uncontrolled congestive heart failure or angina.

3.2.3 Pregnancy or nursing patients will be excluded from the study.

3.2.4 Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.

3.2.5 No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.

3.4 Donor Exclusion Criteria

3.4.1 Serious medical or psychological illness.

3.4.2 Pregnant or lactating women are not eligible

3.4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers

Both
18 Years and older
No
Contact: Physician Referrals (650) 723-0822
United States
 
NCT00896493
BMT206, SU-04062009-2138, 16213
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Wen-Kai Weng Stanford University
Stanford University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP