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

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ClinicalTrials.gov Identifier: NCT00896493

Recruitment Status : Recruiting

First Posted : May 11, 2009

Last Update Posted : October 20, 2016

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Stanford University

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
Mycoses Sezary Syndrome Lymphoma, T-Cell, Cutaneous Bone Marrow Transplant Failure Lymphoma, Non-Hodgkin Cutaneous T-cell Lymphoma	Drug: anti-thymocyte globulin Drug: cyclosporine	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
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 2009
Estimated Primary Completion Date :	December 2022
Estimated Study Completion Date :	December 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Sézary syndrome

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclosporine Antilymphocyte Serum

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Cutaneous T-cell Lymphoma Sezary Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Total lymphoid irradiation & anti-thymocyte immunoglobulin	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: cyclosporin cyclosporin A

Outcome Measures

Primary Outcome Measures :

To evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. [ Time Frame: 2 years ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896493

Contacts


Contact: Physician Referrals	(650) 723-0822

Locations


United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Physician Referrals 650-723-0822
Principal Investigator: Wen-Kai Weng
Sub-Investigator: Ranjana Hira Advani
Sub-Investigator: Sally Arai
Sub-Investigator: Jonathan Benjamin
Sub-Investigator: Richard T. Hoppe
Sub-Investigator: Laura A Johnson
Sub-Investigator: Youn H Kim
Sub-Investigator: Robert Lowsky
Sub-Investigator: David Miklos
Sub-Investigator: Robert S Negrin
Sub-Investigator: Judith Anne Shizuru

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Wen-Kai Weng	Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT00896493 History of Changes
Other Study ID Numbers:	BMT206 SU-04062009-2138 ( Other Identifier: Stanford University ) 16213 ( Other Identifier: Stanford IRB )
First Posted:	May 11, 2009 Key Record Dates
Last Update Posted:	October 20, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:


Lymphoma Lymphoma, T-Cell Mycoses Sezary Syndrome Lymphoma, T-Cell, Cutaneous Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporins	Cyclosporine Antilymphocyte Serum Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors

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