Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma (NCT01130194) | Clinical Trial Compass
CompletedPhase 2
Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma
United States29 participantsStarted 2006-07
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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%
Exclusion Criteria:
* 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,…
What they're measuring
1
Disease-free survival percentage(intention to treat)