Non-Hodgkin's Lymphoma
Conditions
Keywords
B-Cell, non-Hodgkin's, Lymphoma
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 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.
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 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.
Interventions
BIOLOGICALRituximab
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.
DRUGCyclophosphamide
750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
DRUGDoxorubicin
50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
DRUGVincristine
1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
DRUGPrednisone
100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
DRUGIfosfamide
2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
DRUGCarboplatin
Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
DRUGEtoposide
100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
50 mg/kg/day on Days 2-5 of HiCy.
PROCEDUREPET scan
Performed once between Days 16-20 of cycle 3 of R-CHOP.
Sponsors
Genentech, Inc.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One of the following Biopsy-confirmed, aggressive non-Hodgkin's lymphoma 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
* Patients with the following aggressive lymphomas are not eligible: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result. | 5 years |
Countries
United States
Participant flow
Pre-assignment details
1 participant was deemed ineligible and therefore not assigned to intervention. One participant withdrew informed consent prior to starting the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | PET Negative | PET Positive | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 4 Participants | 19 Participants |
| Age, Continuous | 52.5 years | 50 years | 52 years |
| Sex: Female, Male Female | 8 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 0 / 5 |
| other Total, other adverse events | 0 / 20 | 0 / 5 |
| serious Total, serious adverse events | 0 / 20 | 3 / 5 |
Outcome results
Primary
Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan
Time frame: 2 years
Population: 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.
Secondary
Overall Survival in Patients Whose Treatment is Determined on the Basis of a Mid-treatment [18F] FDG-PET Scan Result.
Time frame: 5 years
Population: 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.