Marginal Zone Lymphoma
Conditions
Keywords
Marginal Zone Lymphoma, Non-gastric extranodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Gastric Marginal Zone Lymphoma, MZL, Non-gastric extranodal MZL, Splenic MZL, Nodal MZL, Gastric MZL
Brief summary
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
Detailed description
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
Interventions
DRUGRituximab
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months) * Measurable and evaluable disease * All stages are eligible * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B) * Willing and able to provide written informed consent * Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment * Life expectancy of at least 6 months
Exclusion criteria
* Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment. * ≥ 25% lymphoma bone marrow involvement * Platelet count \< 100,000 cells/mm³ * Neutrophil count \< 1,500 cells/mm³ * Known history of HIV infection * Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection. * Physical or mental condition that makes patient unable to complete specified follow-up assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. | 12 weeks post-therapy | The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Progression-Free Survival | End of study. | The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier. |
| 5-Year Rate of Progression-Free Survival (5-Year PFS) | 5 Years | Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation. |
| Overall Survival (OS) Rate | End of Study | The time from the date of initiation of study treatment until date of death from any cause for all participants. |
| 5 Year Rate of Overall Survival (5-Year OS) | 5 Years | Percentage of participants still alive five years after the date of protocol therapy initiation. |
| Number of Participants With Unacceptable Toxicity. | Up to 12 weeks post-therapy | Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zevalin + Rituximab Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³ | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Zevalin + Rituximab |
|---|---|
| Age, Continuous | 62 years |
| Bone Marrow involvement No | 16 participants |
| Bone Marrow involvement Yes | 0 participants |
| Bulky disease (cm) 5 and less cm | 9 participants |
| Bulky disease (cm) More than 5 cm | 7 participants |
| Disease Stage Stage I/II | 3 participants |
| Disease Stage Stage III/IV | 13 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 14 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 2 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 0 participants |
| Extranodal disease sites 0, 1 sites | 11 participants |
| Extranodal disease sites 2 or more sites | 5 participants |
| Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group High risk | 2 participants |
| Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group Intermediate risk | 7 participants |
| Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group Low risk | 7 participants |
| International Prognostic Index (IPI) Risk Group High risk | 0 participants |
| International Prognostic Index (IPI) Risk Group Intermediate/high risk | 4 participants |
| International Prognostic Index (IPI) Risk Group Low/intermediate risk | 9 participants |
| International Prognostic Index (IPI) Risk Group Low risk | 3 participants |
| Lactate dehydrogenase (LDH) Levels Elevated | 2 participants |
| Lactate dehydrogenase (LDH) Levels Normal | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 16 |
| serious Total, serious adverse events | 2 / 16 |
Outcome results
Primary
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Time frame: 12 weeks post-therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zevalin + Rituximab | Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. | 87.5 percentage of participants |
Secondary
5 Year Rate of Overall Survival (5-Year OS)
Percentage of participants still alive five years after the date of protocol therapy initiation.
Time frame: 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zevalin + Rituximab | 5 Year Rate of Overall Survival (5-Year OS) | 71.8 percentage of participants |
Secondary
5-Year Rate of Progression-Free Survival (5-Year PFS)
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Time frame: 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zevalin + Rituximab | 5-Year Rate of Progression-Free Survival (5-Year PFS) | 40 percentage of participants |
Secondary
Number of Participants With Unacceptable Toxicity.
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Time frame: Up to 12 weeks post-therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zevalin + Rituximab | Number of Participants With Unacceptable Toxicity. | 2 participants |
Secondary
Overall Survival (OS) Rate
The time from the date of initiation of study treatment until date of death from any cause for all participants.
Time frame: End of Study
Population: Median overall survival by Kaplan-Meier method for all patients was not attained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zevalin + Rituximab | Overall Survival (OS) Rate | NA months |
Secondary
Rate of Progression-Free Survival
The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
Time frame: End of study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zevalin + Rituximab | Rate of Progression-Free Survival | 47.6 months |