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

Primary Purpose

Follicular Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination of treatment modalities
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring follicular lymphoma, radioimmunotherapy, rituximab, C-MOPP-R, autologous transplant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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%).

Sites / Locations

  • Saint Louis University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Disease-free survival percentage(intention to treat)

Secondary Outcome Measures

Incidence of second malignancies

Full Information

First Posted
May 24, 2010
Last Updated
May 9, 2014
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT01130194
Brief Title
Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma
Acronym
MasterPlan
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
follicular lymphoma, radioimmunotherapy, rituximab, C-MOPP-R, autologous transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
C-MOPP-R chemotherapy, 6 cycles Peripheral blood stem cell mobilization Radioimmunotherapy Autologous Hematopoietic Stem Cell Transplantation
Intervention Type
Other
Intervention Name(s)
Combination of treatment modalities
Other Intervention Name(s)
Cytoxan, Rituxan, Oncovin, Matulane, Zevalin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival percentage(intention to treat)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Incidence of second malignancies
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Petruska, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark J Fesler, MD
Organizational Affiliation
St. Louis University
Official's Role
Study Director
Facility Information:
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

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Immunochemotherapy, Zevalin, and Bone Marrow Transplant for Follicular Lymphoma

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