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

This study is currently recruiting participants.
Verified July 2013 by St. Louis University
Sponsor:
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT01130194
First received: May 24, 2010
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Follicular Lymphoma
Other: Combination of treatment modalities
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Disease-free survival percentage(intention to treat) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of second malignancies [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: July 2026
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130194

Contacts
Contact: Mark J Fesler, MD 314-577-8854 mfesler@slu.edu
Contact: Cindy Cantrell, RN 314-577-8854 cantrell@slu.edu

Locations
United States, Missouri
Saint Louis University Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cindy Cantrell, RN    314-577-8854    cantrell@slu.edu   
Sub-Investigator: Mark J Fesler, MD         
Principal Investigator: Paul J Petruska, MD         
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Paul J Petruska, MD St. Louis University
Study Director: Mark J Fesler, MD St. Louis University
  More Information

Additional Information:
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.

Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT01130194     History of Changes
Other Study ID Numbers: IRB #14228
Study First Received: May 24, 2010
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
follicular lymphoma
radioimmunotherapy
rituximab
C-MOPP-R
autologous transplant

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 21, 2014