Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL

Stopped early · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00077961

Run by

Genzyme, a Sanofi Company

People needed

49

Starts

2003-12-01

Last updated by the study team

2015-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Colorado Springs, Colorado, United States
• Study site — Ocala, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Lafayette, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Columbia, Missouri, United States
• Study site — Manhasset, New York, United States
• Study site — Cary, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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