Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
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|ClinicalTrials.gov Identifier: NCT00057967|
Recruitment Status : Active, not recruiting
First Posted : April 9, 2003
Last Update Posted : September 11, 2017
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: alemtuzumab||Phase 2|
- Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome|
|Study Start Date :||July 2000|
|Estimated Primary Completion Date :||August 18, 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: Treatment arm
Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks.
- Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome [ Time Frame: At baseline, weekly while on treatment, then once when patient goes off study ]Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study
- Collect data on toxicity associated with Campath-1H therapy [ Time Frame: At baseline and then every 2 weeks while on therapy ]Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057967
|United States, Illinois|
|Northwestern University, Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611-3013|
|Veterans Affairs Medical Center - Lakeside Chicago|
|Chicago, Illinois, United States, 60611-4494|
|Principal Investigator:||Timothy M. Kuzel, MD||Northwestern University|