Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a subcutaneous PORT. This combination chemotherapy will last six months. After the last dose of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil. Patients then receive Zevalin radioimmunotherapy, and this is followed after recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.

Official Title
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A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Other: Combination of treatment modalities


Participation Criteria
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Eligibility Criteria
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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 < 100,000) 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%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation | Other: Combination of treatment modalities<br>* Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total. Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning.<br>* Other names: Zevalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival percentage(intention to treat) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of second malignancies |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follicular lymphoma, radioimmunotherapy, rituximab, C-MOPP-R, autologous transplant