MasterPlan: Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

Sponsor

St. Louis University (Other)

Overall Status

Completed

CT.gov ID

NCT01130194

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Other: Combination of treatment modalities	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation	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. Other Names: Cytoxan Rituxan Oncovin Matulane Zevalin

Arm

Intervention/Treatment

Experimental: Experimental

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

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.

Other Names:

Cytoxan

Rituxan

Oncovin

Matulane

Zevalin

Outcome Measures

Primary Outcome Measures

Disease-free survival percentage(intention to treat) [5 years]

Secondary Outcome Measures

Incidence of second malignancies [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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%).