Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

Completed · Phase 2

Conditions studied: Follicular Lymphoma

In brief

Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. The investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.

Key facts

Study ID

NCT01130194

Run by

St. Louis University

People needed

29

Starts

2006-07-01

Expected to finish

2012-06-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients older than 18 years of age
• Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens
• Relapse of disease must be greater than 6 months after last chemotherapy
• Stages II, III or IV
• Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator.
• Patient signed written informed consent
• Adequate renal function defined as a glomerular filtration rate (GFR) > 60 ml/min
• Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow.
• No known allergies to the chemotherapeutic agents
• No other major disabling co morbidities
• Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted and FEV1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted.
• Adequate hepatic function as assessed by study investigator
• Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a test of heart function) >50%

You may not qualify if…

• Stage I follicular lymphoma
• ECOG performance status ≥ 2, unless due to lymphoma
• Patient refuses to sign written informed consent
• Poor renal function defined as GFR <60ml/min
• Abnormal liver function as assessed by study investigator
• Poor bone marrow reserve (absolute neutrophil count <1,500 and/or platelets < 100,000) not attributable to lymphomatous involvement of the bone marrow.
• Hypersensitivity to the chemotherapeutic agents
• Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis.
• Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed <5 years prior.
• Central nervous system disease
• History of advanced cardiac disease (Active angina, Congestive heart failure with a LVEF (left ventricular ejection fraction) <50%).

Where it is running

• Saint Louis University Cancer Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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