Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

Follicular Lymphoma Clinical Trial

— MasterPlan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130194
• Other study ID #: IRB #14228
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2010
• Last updated: May 9, 2014
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: May 2014
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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%).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Saint Louis University Cancer Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival percentage(intention to treat)		5 years	No
Secondary	Incidence of second malignancies		5 years	Yes