Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

NCT ID: NCT01130194

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-06-30

Brief 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.

Detailed 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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Combination of treatment modalities

Intervention Type: OTHER

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.

Interventions

Combination of treatment modalities

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.

Intervention Type: OTHER

Other Intervention Names

Cytoxan; Rituxan; Oncovin; Matulane; Zevalin

Eligibility Criteria

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%).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul J Petruska, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Mark J Fesler, MD

Role: STUDY_DIRECTOR

St. Louis University

Locations

Saint Louis University Cancer Center

St Louis, Missouri, United States

Countries

United States

References

Fesler MJ, Osman M, Glauber J, Petruska PJ. C-MOPP: Results of a Forgotten Regimen in the Era of Rituximab and PET. Blood (ASH Annual Meeting Abstracts 2009) #4577.

Reference Type: RESULT

Other Identifiers

IRB #14228

Identifier Type: -

Identifier Source: org_study_id