The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.

Condition	Treatment or Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: CAMPATH (alemtuzumab)	Phase I Phase II

This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Patients must have:

• Pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory
• Previously treated wiht at least one anti-cancer regimen for NHL
• Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of 1cm or more or palpable lesions with both diameters of 2cm or more)
• Life expectancy of at least 12 weeks
• WHO performance status or 0 or 1
• Adequate marrow and organ function (as defined in the protocol)
• Anti-cancer therapy, major surgery, or radiation therapy must have been completed at least 3 weeks prior to enrollment in this study. Patients must have recovered from the acute side effects of the previous therapy

Exclusion Criteria: Patients must not have:

• Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is acceptable
• A history of a T-cell lymphoma
• For the Phase II portion of the study (once MTD has been determined), bukly disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more
• Prior autologous bone marrow or stem cell transplant within 6 months of study entry
• Prior allogeneic bone marrow transplant or organ transplant
• Prior radiotherapy to the only site of measurable disease
• Medical condition requiring chronic use of oral, high-dose corticosteroids
• Use of investigational agents within 30 days of study enrollment
• Past history of anaphylaxis following exposure to humanized monoclonal antibodies
• Known, active, infection, including HIV positive
• Active secondary malignancy
• Active central nervous system (CNS) involvement with lymphoma
• Pregnant or nursing women
• Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results

Reyna Bishop, MS      210-949-8456    rbishop@ilexonc.com
Kimberly Mitchell, RN      210-949-8315    kmitchell@ilexonc.com

Colorado
      Colorado Springs,  Colorado,  80909,  United States; Not yet recruiting
Florida
      Ocala,  Florida,  34474,  United States; Not yet recruiting
Illinois
      Park Ridge,  Illinois,  60068,  United States; Recruiting
Louisiana
      Lafayette,  Louisiana,  70506,  United States; Recruiting
      New Orleans,  Louisiana,  70115,  United States; Recruiting
Missouri
      Columbia,  Missouri,  65201,  United States; Not yet recruiting
New York
      Manhasset,  New York,  11030,  United States; Recruiting
North Carolina
      Cary,  North Carolina,  27511,  United States; Not yet recruiting
Ohio
      Canton,  Ohio,  44718,  United States; Recruiting
South Carolina
      Greenville,  South Carolina,  29615,  United States; Not yet recruiting

Study ID Numbers:  CAM.NHL233
Record last reviewed:  February 2004
Record first received:  February 13, 2004
ClinicalTrials.gov Identifier:  NCT00077961
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10