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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center Genentech |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00809341 |
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.
The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.
We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.
The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: R-CHOP, R-CHOEP, R-EPOCH Drug: R-ICE, Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning |
Estimated Enrollment: | 55 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2014 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PET Negative: Active Comparator
PET Negative
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Drug: R-CHOP, R-CHOEP, R-EPOCH
Based on the PET-CT scan results patients will complete standard chemotherapy consisting of R-CHOP (or equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH)
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PET Positive: Active Comparator
PET Positive
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Drug: R-ICE, Cyclophosphamide
Two cycles of R-ICE, followed by high dose cyclophosphamide and Rituximab
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma
Exclusion Criteria:
Patients with the following aggressive lymphomas are not eligible:
Contact: Lode Swinnen, MD | 410-614-6398 | lswinne1@jhmi.edu |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 |
Principal Investigator: | Lode Swinnen, MD | Johns Hopkins University |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center ( Lode Swinnen, MD ) |
Study ID Numbers: | J0802, NA_00013656 |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809341 |
Health Authority: | United States: Institutional Review Board |
B-Cell non-Hodgkin's Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Rituximab B-cell lymphomas |
Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |