This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT \< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.
Primary Objective: This study objective is to document the incidence of complete responses compared to oral vorinostat, in a randomized 2-arm trial after a maximum of 12 months of treatment for subjects with stage IB/IIB mycosis fungoides with mSWAT \< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant. Secondary Objective: To further explore the toxicity profile of A-dmDT390-bisFv(UCHT1) fusion protein for subjects with mycosis fungoides who have been selected to be free from preexisting cardiac disease and never treated with Campath. Number of Subjects: Lead-in Dosing: 12 / Randomized: 162 Patients will receive full supportive care during the course of the study. Participation in the study will require IV infusions of the research agent 2 times a day for four days (protocol FDA outpatient approved), as well as frequent outpatient blood draws for the first 30 days. Patients with partial or complete remissions at their 1 month follow up visit will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)
ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
Incidence of Complete Responses (CR)
Evaluation of Target Lesions Complete Response (CR) in mycosis fungoides: (a) Cutaneous lesions consisting of erythematous patches and plaques and erythroderma must be absent giving an mSWAT of 0 that persists for at least 30 days, and (b) the spleen and liver should be normal sized by physical exam. Subjects in the experimental arm who have a CR at 12 months will be encouraged to enter the Part B followup that consists of a a yearly physical exam from year 2 to year to year 6 and skin assessment as long as the CR is maintained. Partial Response (PR) in mycosis fungoides: (a) There must be a reduction of 50% in cutaneous lesions as judged by mSWAT and (b) no new evidence of disease or disease progression of skin lesions. Progressive Disease (PD): At least a 25% increase in the mSWAT score from its nadir value. Treatment Failure: Failure to achieve a PR or CR: Relapse/Progression: Relapse is defined at reevaluation as no longer a CR or PR.
Time frame: Skin lesions will be judged for mSWAT scores for judging the duration of response at 12 months in the experimental arm and 6 months in the comparator arm.
Progression Free Survival
Determine the Progression Free Survival duration, PFS
Time frame: 12 months
Median duration of Complete Response
Determine the Median duration of CR for each arm.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.