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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01130194
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : May 12, 2014
Information provided by (Responsible Party):
St. Louis University

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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 : July 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

Primary Outcome Measures :
  1. Disease-free survival percentage(intention to treat) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of second malignancies [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01130194

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United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
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Principal Investigator: Paul J Petruska, MD St. Louis University
Study Director: Mark J Fesler, MD St. Louis University

Publications of Results:
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.

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Responsible Party: St. Louis University Identifier: NCT01130194     History of Changes
Other Study ID Numbers: IRB #14228
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by St. Louis University:
follicular lymphoma
autologous transplant

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