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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01311 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PSOC 2301 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have had their first decrease in or disappearance of signs and symptoms of cancer (first remission). Monoclonal antibodies, such as tositumomab and iodine I 131 tositumomab, may block cancer growth in different ways by targeting certain cells.
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival at 2 years following administration of 131I-tositumomab (tositumomab and iodine I 131 tositumomab) in patients with CLL/SLL who achieve a complete remission (CR) or partial remission (PR) with prior therapy.
II. To improve the response rate by administering 131I-tositumomab to patients who have achieved a PR not a CR after any prior therapy.
III. To eliminate residual disease (documented by flow cytometry or polymerase chain reaction [PCR]) using 131I-tositumomab in patients who have achieved a CR after any prior therapy.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of 131I-tositumomab in 1st remission patients with previously treated CLL/SLL.
OUTLINE:
Patients receive tositumomab and iodine I 131 tositumomab intravenously (IV) over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.
After completion of study treatment, patients are followed up weekly for 3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (monoclonal antibody therapy) | Experimental | Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tositumomab and Iodine I 131 Tositumomab | Combination Product | Give IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Probability of Progression-free Survival (PFS) | Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months. | 36 months |
| Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy | Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab. | 3 months after 131I-tositumomab consolidation |
| Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy | 3 months after 131I-tositumomab consolidation |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Toxicities of 131I-tositumomab | Adverse events following treatment of 131I-tositumomab | 48 months (median) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazyar Shadman | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Monoclonal Antibody Therapy) | Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Completed Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Monoclonal Antibody Therapy) | Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| CLL or SLL | Count of Participants | Participants |
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| Prior chemotherapy | Count of Participants | Participants |
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| Disease status before 131 I-tositumomab | CRITERIA FOR RESPONSE Criteria for response are specified by the NCI working group guidelines; in addition, patients will be required to meet computed tomography (CT) scan criteria as defined in the protocol. Complete response (CR) Partial response (PR) Progressive Disease (PD) Stable Disease (SD) | Count of Participants | Participants |
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| Minimal Residual Disease (MRD) status before 131 I-tositumomab | MRD was assessed on bone marrow samples using 8 color flow cytometry to detect CLL/SLL cells. Any level of residual disease by flow cytometry or cytogenetics was considered MRD positive. Negativity of both tests was required to classify a patient as MRD negative. | Count of Participants | Participants |
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| 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 | Probability of Progression-free Survival (PFS) | Progression free survival (PFS) is defined as the interval between the first treatment day to the first sign of disease progression. This outcome measures the percentage of participants with PFS at 36 months. | Posted | Number | 95% Confidence Interval | percentage probability | 36 months |
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| Primary | Improved Response Rate After Treatment With 131I-tositumomab for Patients Who Had Evidence of CLL at the End of Initial Chemotherapy | Response rates determined using National Cancer Institute (NCI) working group guidelines plus computed tomography (CT) scan criteria. Participants were assessed for response after initial chemotherapy and again 3 months after 131I-tositumomab treatment.Only patients who had less than a complete response (CR) after initial chemotherapy were assessed for improved response after 131I-tositumomab. | Participants who had a partial response (PR) after initial chemotherapy. Response assessed using NCI working group guidelines + CT criteria as described in the protocol. | Posted | Count of Participants | Participants | 3 months after 131I-tositumomab consolidation |
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| Primary | Minimal Residual Disease (MRD) by Flow Cytometry or Polymerase Chain Reaction (PCR) in Patients Who Had a Complete Remission (CR) After Any Prior Therapy | Posted | Count of Participants | Participants | No | 3 months after 131I-tositumomab consolidation |
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| Secondary | Evaluate Toxicities of 131I-tositumomab | Adverse events following treatment of 131I-tositumomab | Posted | Number | participants with this toxicity | 48 months (median) |
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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 | Treatment (Monoclonal Antibody Therapy) | Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes. Tositumomab and Iodine I 131 Tositumomab: Give IV Laboratory Biomarker Analysis: Correlative studies | 0 | 16 | 16 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia Grade 3 or 4 | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia Grade 3 or 4 | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mazyar Shadman, MD | Fred Hutchinson Cancer Research Ctr | 2066675467 | mshadman@fredhutch.org |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C119496 | tositumomab I-131 |
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| BR (bendamustine and rituximab) |
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| R-CHOP |
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| Title |
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| Title | Denominators | Categories | ||||
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| Grade 3 anemia |
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| Grade 3 or 4 neutropenia |
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| Grade 3 or 4 thrombocytopenia |
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| Hypogammaglobulinemia |
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| Neutropenia related sepsis/typhlitis |
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| Basal cell carcinoma |
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| Squamous cell carcinoma |
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| Myelodysplastic syndrome |
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