Status:
TERMINATED
R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Lymp...
Detailed 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 sca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00809341
Start Date
January 1 2009
End Date
April 1 2014
Last Update
September 25 2018
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231