R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT00809341
Last Updated: 2018-09-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
27 participants
INTERVENTIONAL
2009-01-31
2014-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PET Negative
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist.
Rituximab
375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy.
Cyclophosphamide
750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Doxorubicin
50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Vincristine
1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Prednisone
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
PET scan
Performed once between Days 16-20 of cycle 3 of R-CHOP.
PET Positive
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide).
Rituximab
375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy.
Cyclophosphamide
750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Doxorubicin
50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Vincristine
1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Prednisone
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
Ifosfamide
2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
Carboplatin
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
Etoposide
100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
High-dose cyclophosphamide
50 mg/kg/day on Days 2-5 of HiCy.
PET scan
Performed once between Days 16-20 of cycle 3 of R-CHOP.
Interventions
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Rituximab
375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy.
Cyclophosphamide
750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Doxorubicin
50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Vincristine
1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
Prednisone
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
Ifosfamide
2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
Carboplatin
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
Etoposide
100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
High-dose cyclophosphamide
50 mg/kg/day on Days 2-5 of HiCy.
PET scan
Performed once between Days 16-20 of cycle 3 of R-CHOP.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Diffuse large B-cell lymphoma
2. 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
1. Mantle cell
2. Lymphoblastic
3. Burkitt's
4. Mycosis fungoides/Sezary's syndrome
5. HTLV-1 associated T-cell leukemia/lymphoma
6. Primary CNS lymphoma
7. HIV-associated lymphoma
8. Transformed lymphomas
9. 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Lode Swinnen, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NA_00013656
Identifier Type: OTHER
Identifier Source: secondary_id
J0802
Identifier Type: OTHER
Identifier Source: secondary_id
J0802
Identifier Type: -
Identifier Source: org_study_id
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