Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A
The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Cutaneous T Cell Lymphoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A|
- The primary endpoint will be the overall response based on skin-weighted assessment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]The overall skin repsonse will be assessed at 6month and will consist of an experts assessment of the % of skin involvement at baseline and 6 months.
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]A quality of life questinaire will be completed by the patient at 6months of tretament and 6 months after end of tretament
|Study Start Date:||September 2004|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
UVVADEX +ECP will be administered to patients with CTCL.Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue.
UVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months
Other Name: Uvadex
Objectives: The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.
Methodology: Single-arm, open-label treatment using UVAR XTS Photopheresis System. Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months. Those patients completing the first 6-month period may be continued on photopheresis for a 6-month follow-up period. Patients who do not respond to photopheresis therapy after 6 months may have concurrent therapy with low dose bexarotene and interferon added as outlined in the protocol.
Number of Patients (Planned and Analyzed): The study plan is for a minimum of 50 patients
Diagnosis and Main Criteria for Inclusion: Male or female patients with CTCL diagnosis of stage IA, IB or IIA with measurable skin lesions (patches or plaques) and a minor blood abnormality. Patients must be refractory to at least one treatment for early stage CTCL such as PUVA, Electron beam, oral steroids, high potency topical steroid, topical nitrogen mustard, methotrexate, interferon, or bexarotene.
Test Product, Dose and Mode of Administration, Batch or Lot Number: UVADEX liquid methoxsalen 20mcg/mL in conjunction with the UVAR XTS Photopheresis System. UVADEX is injected into the photoactivation bag during photopheresis therapy in accordance with the approved drug package insert and UVAR XTS operator's manual. UVADEX dose is less than 200mcg per treatment.
Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue.
Criteria for Evaluation:
Efficacy: The primary endpoint will be the overall response based on skin-weighted assessment. Secondary endpoints will also include time to response, duration of response, and a "Quality of Life " assessment. The size and number of lymph nodes and flow cytometry analyses will also be considered. Experienced skin observers will perform skin scores on each patient at enrollment. Skin scores will be recorded as the percentage of the patient's body involved with patch or plaque lesions. A successful response to therapy will be patients who have a greater than 50% improvement in skin involvement (PR) or complete skin improvement (CR) without worsening in nodes, blood or visceral organs. Patients with 25%-50% improvement will be considered as minor response (MR), + or - 25% will be SD, and PD will be defined as 25% worsening from baseline.
Safety: Safety is assessed by the incidence and intensity of adverse events, whether clinical or based on laboratory results.
Statistical Methods: The primary endpoint will be the proportion of patients who have CR and PR of their skin lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221039
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Ohio|
|University Hospital of Cleveland/Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Madeleine Duvic, MD||M.D. Anderson Cancer Center|