Non Hodgkin Lymphoma Clinical Trial
R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin’s Lymphoma
Summary
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.
Full Description
Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT. Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be designated as negative or positive. Based on the results, patients will either complete standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide and rituximab.
A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.
Eligibility Criteria
Inclusion Criteria:
One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma
Diffuse large B-cell lymphoma
Mediastinal (thymic) B-cell lymphoma
Any stage (I through IV) as defined by the Ann Arbor staging system
ECOG performance status of 0 to 2
Radiographically measurable disease
No more than 3 cycles of chemotherapy for lymphoma
Greater than or equal to 18 years
Adequate pulmonary, cardiac, hepatic, or renal function
HIV antibody negative
Women- Not pregnant or breastfeeding
Men of reproductive potential must agree to use contraception
Exclusion Criteria:
Patients with the following aggressive lymphomas are not eligible:
Mantle cell
Lymphoblastic
Burkitt's
Mycosis fungoides/Sezary's syndrome
HTLV-1 associated T-cell leukemia/lymphoma
Primary CNS lymphoma
HIV-associated lymphoma
Transformed lymphomas
Immunodeficiency-associated lymphomas
Previous diagnosis of another hematologic malignancies
Progressive disease on CHOP or Rituximab-CHOP
Active CNS involvement by lymphoma
Serious co-morbid disease that could preclude full participation in study
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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