Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

NCT01130194 | Completed Phase 2 DMC

• 1 other identifier: IRB #14228
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Follicular Lymphoma

Keywords

follicular lymphoma; radioimmunotherapy; rituximab; C-MOPP-R; autologous transplant

Outcome Measures

Primary Outcomes (1)

• Disease-free survival percentage(intention to treat)

  5 years

Secondary Outcomes (1)

• Incidence of second malignancies

  5 years

Study Arms (1)

Experimental

EXPERIMENTAL

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

Other: Combination of treatment modalities

Interventions

Combination of treatment modalities OTHER

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.

Also known as: Cytoxan, Rituxan, Oncovin, Matulane, Zevalin

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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%).

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Related 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.

  RESULT

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Cyclophosphamide; Rituximab; Vincristine; Procarbazine; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Paul J Petruska, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Mark J Fesler, MD

  St. Louis University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 25, 2010
• Study Start: July 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (1)