- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130194
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
Intervention / 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.
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
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-
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:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #14228
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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