Non-Hodgkin's Lymphoma
Conditions
Keywords
Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan
Brief summary
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
Detailed description
The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.
Interventions
DRUGIbritumomab Tiuxetan (Zevalin) + Rituximab
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
Sponsors
Genentech, Inc.
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3 * Meeting FLIPI criteria for intermediate or high risk. * No prior chemotherapy, radiotherapy or immunotherapy for lymphoma; * Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.
Exclusion criteria
* May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression Free Survival (PFS) | up to 5 years, 9.5 months, from first day on treatment to last follow up | Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | At 12 months | To estimate overall survival, 95% confidence intervals will be used. |
| 24-month Progression Free Survival (PFS) | Up to 24 months | Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months. Progression is defined as any of the following: \- Appearances of any new lesions/sites during or after therapy. * Increase of \>/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site. * Increase by \> 50% in greatest diameter from nadir measurement of any previously involved dominant node \> 1.0 cm in its short axis. |
| Response Rates | Up to 5 years and 9.5 months | To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a \> 1.5cm residual node that has decreased by \>75%, and/or individual nodes that were previously confluent that have decreased by \>75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). |
| Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0 | Up to 5 years and 9.5 months | To record the toxicities associated with this regimen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zevalin With Rituximab Maintenance Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Ineligible pathology | 1 |
Baseline characteristics
| Characteristic | Zevalin With Rituximab Maintenance |
|---|---|
| Age, Continuous | 55 years |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 15 / 16 |
| serious Total, serious adverse events | 5 / 16 |
Outcome results
Primary
Median Progression Free Survival (PFS)
Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).
Time frame: up to 5 years, 9.5 months, from first day on treatment to last follow up
Population: The study was stopped prematurely, subjects were not followed for a full 7 years. We have data for 16 subjects, 6 experienced a progression event, 10 survived progression-free through last follow-up. Date of last follow-up is used to calculate progression-free survival for those who did not experience progression.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zevalin With Rituximab Maintenance | Median Progression Free Survival (PFS) | 44.3 months |
Secondary
24-month Progression Free Survival (PFS)
Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months. Progression is defined as any of the following: \- Appearances of any new lesions/sites during or after therapy. * Increase of \>/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site. * Increase by \> 50% in greatest diameter from nadir measurement of any previously involved dominant node \> 1.0 cm in its short axis.
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zevalin With Rituximab Maintenance | 24-month Progression Free Survival (PFS) | 11 Participants |
Secondary
Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0
To record the toxicities associated with this regimen.
Time frame: Up to 5 years and 9.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zevalin With Rituximab Maintenance | Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0 | 16 Participants |
Secondary
Overall Survival (OS)
To estimate overall survival, 95% confidence intervals will be used.
Time frame: At 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zevalin With Rituximab Maintenance | Overall Survival (OS) | 93 percentage of participants |
Secondary
Response Rates
To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a \> 1.5cm residual node that has decreased by \>75%, and/or individual nodes that were previously confluent that have decreased by \>75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Time frame: Up to 5 years and 9.5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zevalin With Rituximab Maintenance | Response Rates | 44 percentage of participants |