None listed
Conditions
Interventions
First, a prior hydration will be performed with 5% Dextrose 1000 cc + Kalium (01 ampoule) + Hipersodium (01 ampoule) + Sodium bicarbonate (02 ampoules) in 700 cc administered in one hour. After this, Methylprednisolone 100 mg EV with Chlorpheniramine 15 mg EV and Paracetamol 500 mg VO will be administered. 30 minutes after this premedication Alemtuzumab (CAMPATH 1-H) 3 mg in NaCl 0.9% in 200 cc in 2 to 4 hours will be administered. The dose will gradually increase to 30 mg. The aforementioned sc
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histopathological diagnosis of Mycosis Fungoides / Sezary Syndrome. 2) Have received up to three treatments with chemotherapy previously. 3) Patient> of 18 years. 4) You may have previously received radiation therapy. 5) Transaminase and alkaline phosphatase values not higher than double the maximum limit value of normality bilirubin 10mg / dl, neutrophils> 1,500 mm3. 7) Platelets> 100,000 mm3. 8) EC0G <2.
Exclusion criteria
Exclusion criteria: 1) Clinical stage I. 2) Age> 75 years. 3) Creatinine clearance less than 50cc / ml. 4) ECOG equal to or greater than 3. 5) Active infection. 6) Pregnancy, lactation. 7) HIV positive. 8) Patient with Mycosis Fungoide / Sezary Syndrome with transformation. 9) Renal insufficiency. 10) Hepatic insufficiency. 11) Psychiatric disorder. 12) Carrier of a second neoplasm. 13) Female patients of childbearing age, with positive pregnancy test. 14) Serology HTLV-1/2 positive. 15) Have received chemotherapy within one month of inclusion in the study. 16) History of myocardial infarction, congestive heart failure or dilated cardiomyopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Thoracic-abdomino-pelvic computed tomography. Complete blood count. Cytometry of peripheral blood flow. Bone marrow biopsy. Skin biopsy Measure:1) Absence of signs of illness. 2) Absence of new injuries. 3) Absence of lymph nodes> 1cm palpable and in tomography <1.5 cm. 4) Absence of circulating neoplastic lymphocytes. 5) Normal skin. 6) Negative bone marrow aspiration if initially positive. 7) The complete response will be confirmed by a negative skin biopsy for a period greater than one month. Timepoints:Clinical evaluation: At the beginning of each week / cycle. Thoracic-abdomino-pelvic computed tomography: 4th, 8th and 12th weeks Complete blood count: At the beginning of each week / cycle. Peripheral blood flow cytometry: At the end of the 12th week. Bone marrow biopsy: At the end of the 12th week. Skin biopsy: At the end of the 12th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:PARTIAL RESPONSE: 1) Reduction of 50% of the basal, of the sum of the largest perpendicular diameters, in all the evaluable and measurable lymph nodes and 5 predefined representative skin lesions respectively. 2) No development of new injuries. Timepoints:At the beginning of each week / cycle. ; Outcome name:Clinical evaluation Measure: 514/5000 STABILIZATION OF THE DISEASE: 1) Decrease of less than 50% of the basal, of the sum of the largest perpendicular diameters, in all the evaluable and measurable lymph nodes and 5 predefined representative skin lesions, respectively. 2) Less than 50% increase in nadir, the sum of the largest perpendicular diameters, in all evaluable and measurable lymph nodes and 5 predefined representative skin lesions, respectively. 3) No development of new injuries. Timepoints:At the beginning of each week / cycle. ; Outcome name:Clinical evaluation Measure:PROGRESSION OF THE DISEASE: 1) More than 50% increase of the nadir, of the sum of the largest perpendicular diameters, in all the evaluable and measurable lymph nodes and 5 predefined representative skin lesions, respectively. 2) Development of new injuries. Timepoints:At the beginning of each week / cycle. | — |
Countries
Peru
Outcome results
None listed