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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00013656 | Other Identifier | JHMIRB | |
| J0802 | Other Identifier | SKCCCRO |
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Low accrual
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET Negative | Active Comparator | 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. |
|
| PET Positive | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result. | 5 years |
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Inclusion Criteria:
One of the following Biopsy-confirmed, aggressive non-Hodgkin's 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:
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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| Name | Affiliation | Role |
|---|---|---|
| Lode Swinnen, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
1 participant was deemed ineligible and therefore not assigned to intervention. One participant withdrew informed consent prior to starting the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET Negative | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cyclophosphamide | Drug | 750 mg/m^2 on Day 1 of each cycle as part of R-CHOP. |
|
|
| Doxorubicin | Drug | 50 mg/m^2 on Day 1 of each cycle as part of R-CHOP. |
|
|
| Vincristine | Drug | 1.4 mg/m^2 on Day 1 of each cycle as part of R-CHOP. |
|
|
| Prednisone | Drug | 100 mg/day on Days 1-5 of each cycle as part of R-CHOP. |
|
| Ifosfamide | Drug | 2000 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP. |
|
|
| Carboplatin | Drug | Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function. |
|
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| Etoposide | Drug | 100 mg/m^2/day on Days 1-3 of each cycle as part of R-CHOP. |
|
|
| High-dose cyclophosphamide | Drug | 50 mg/kg/day on Days 2-5 of HiCy. |
|
|
| PET scan | Procedure | Performed once between Days 16-20 of cycle 3 of R-CHOP. |
|
|
| FG001 | PET Positive | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PET Negative | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. |
| BG001 | PET Positive | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan | The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found. | Posted | 2 years |
|
| |||||||||||||||||||||||
| Secondary | Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result. | The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found. | Posted | 5 years |
|
Up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET Negative | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. | 1 | 20 | 0 | 20 | 0 | 20 |
| EG001 | PET Positive | Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status. | 0 | 5 | 3 | 5 | 0 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, CNS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lode Swinnen | Johns Hopkins Sidney Kimmel Cancer Center | 410-955-8603 | lswinne1@jhmi.edu |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D007069 | Ifosfamide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| >=65 years |
|
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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