Clinical trial NCT00077961: Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL
Official title: Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma
NHL
CAMPATH
alemtuzumab
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-02-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* For the Phase I portion of the study, 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. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory.
* Previously treated with 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 \>/= to 2cm 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)
* Completed major surgery, radiotherapy, chemotherapy, immunotherapy or biotherapy/targeted therapies at least 4 weeks prior to study entry (6 weeks if treated with a nitrosourea or mitomycin). Patients must have recovered from all prior treatment toxicity to Grade 1 or less, exclusive of alopecia.

Exclusion Criteria:

* Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
* A history of a T-cell lymphoma
* Known AIDS-related HIV-positive lymphoma
* For the Phase II portion of the study (once MTD has been determined), bulky 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
* Diagnosis of another malignancy within the previous five (5) years, unless the probability of recurrence of the prior malignancy is \< 5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), and patients with a history of malignant tumor in the past that have been disease-free for at least 5 years
* 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
* Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
state: Colorado
city: Ocala
country: United States
state: Florida
city: Park Ridge
country: United States
state: Illinois
city: Lafayette
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Columbia
country: United States
state: Missouri
city: Manhasset
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: