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Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Mycosis Fungoides, Sezary Syndrome

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Trial Information

Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome


- 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are
scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days
during the first week, followed by 30 mg three times a week until 12 weeks.

- Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and
until three different regimens of chemotherapy.

- Follow up for one year after last cycle of alemtuzumab.


Inclusion Criteria:



- Above 18 years old

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Liver and renal function test less than twice upper label

- No active infection

- Written informed consent

- One to three regimens of previous chemotherapies

Exclusion Criteria:

- Abnormal renal or hepatic function

- Mycosis fungoides/Sezary syndrome in transformation

- HIV +

- HTLV-1 +

- Pregnancy

- Lactation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Principal Investigator

Brady E Beltran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

LACOGH - PERU

Authority:

Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Study ID:

MF/SS

NCT ID:

NCT00157274

Start Date:

July 2005

Completion Date:

July 2008

Related Keywords:

  • Mycosis Fungoides
  • Sezary Syndrome
  • Alemtuzumab
  • Mycosis fungoides
  • Sezary
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

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