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

May 9, 2014 updated by: St. Louis University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation

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:
  • Rituxan
  • Cytoxan
  • Oncovin
  • Zevalin
  • Matulane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of second malignancies
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul J Petruska, MD, St. Louis University
  • Study Director: Mark J Fesler, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (ESTIMATE)

May 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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