Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma (MasterPlan)

Saint Louis University (SLU)

Status and phase: Completed; Phase 2

Conditions: Follicular Lymphoma

Treatments: Other: Combination of treatment modalities

Study type: Interventional

Funder types: Other

Identifiers

NCT01130194

IRB #14228

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Experimental

Experimental group

Description:

C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation

Treatment:

Other: Combination of treatment modalities