PHASE II STUDY OF ALEMTUZUMAB (CAMPATH-1H) IN PATIENTS WITH FUNGOID MICOSIS / ADVANCED SEZARY SYNDROME

Not Applicable

• Conditions: -C840 Mycosis fungoides-C841 Sezary disease; Mycosis fungoides; Sezary disease; C840; C841

• Registration Number: PER-034-05
• Lead Sponsor: SCHERING PLOUGH DEL PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

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 <2 mg / dL.
6) Adequate bone marrow reserve: Hemoglobin> 10mg / dl, neutrophils> 1,500 mm3.
7) Platelets> 100,000 mm3.
8) EC0G <2.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation<br>Thoracic-abdomino-pelvic computed tomography.<br>Complete blood count.<br>Cytometry of peripheral blood flow.<br>Bone marrow biopsy.<br>Skin biopsy<br>Measure:1) Absence of signs of illness.<br>2) Absence of new injuries.<br>3) Absence of lymph nodes> 1cm palpable and in tomography <1.5 cm.<br>4) Absence of circulating neoplastic lymphocytes.<br>5) Normal skin.<br>6) Negative bone marrow aspiration if initially positive.<br>7) The complete response will be confirmed by a negative skin biopsy for a period greater than one month.<br>Timepoints:Clinical evaluation: At the beginning of each week / cycle.<br>Thoracic-abdomino-pelvic computed tomography: 4th, 8th and 12th weeks<br>Complete blood count: At the beginning of each week / cycle.<br>Peripheral blood flow cytometry: At the end of the 12th week.<br>Bone marrow biopsy: At the end of the 12th week.<br>Skin biopsy: At the end of the 12th week.<br>