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| Name | Class |
|---|---|
| City of Hope Medical Center | OTHER |
| Amsterdam UMC, location VUmc | OTHER |
| University of Göttingen | OTHER |
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The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-BEAM | Experimental | ibritumomab tiuxetan (zevalin) BEAM |
|
| standard BEAM | Active Comparator | standard BEAM chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibritumomab tiuxetan | Drug | 0.4 mCi/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | actuarial 2 year survival | 2 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | actuarial 2-year PFS | 2 years after transplantation |
| Clinical Response | complete response (CR) and partial response (PR) proportion at day 100, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avichai Shimoni, MD | Chaim Sheba Medical Center, Tel Hashomer, Israel | Study Chair |
| Amrita Krishnan, MD | City of Hope National Medical Center, Duarte, CA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | United States | |||
| City of Hope National Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Z-BEAM | ibritumomab tiuxetan (zevalin) BEAM ibritumomab tiuxetan: 0.4 mCi/kg BEAM chemotherapy and autologous stem-cell transplantation |
| FG001 | Standard BEAM | standard BEAM chemotherapy BEAM chemotherapy and autologous stem-cell transplantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Z-BEAM | ibritumomab tiuxetan (zevalin) BEAM ibritumomab tiuxetan: 0.4 mCi/kg BEAM chemotherapy and autologous stem-cell transplantation |
| BG001 | Standard BEAM | standard BEAM chemotherapy BEAM chemotherapy and autologous stem-cell transplantation |
| 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 |
| 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 | Overall Survival | actuarial 2 year survival | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years after transplantation |
|
|
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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 | Z-BEAM | ibritumomab tiuxetan (zevalin) BEAM ibritumomab tiuxetan: 0.4 mCi/kg BEAM chemotherapy and autologous stem-cell transplantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| JC virus encephalitis | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Avichai Shimoni | Chaim Sheba Medical Center | 972 3 530 5303 | ashimoni@sheba.health.gov.il |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
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| BEAM chemotherapy and autologous stem-cell transplantation | Procedure |
|
| 100 days after transplantation |
| Hematopoietic Recovery | time to hematopoietic recovery | 100 days after transplantation |
| Grade III Toxicity | incidence of infection, grade III-IV toxicities, treatment-related mortality | 100 days after transplantation |
| Secondary Malignancies | incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML). | 5 years after transplantation |
| Duarte |
| California |
| 91010-3000 |
| United States |
| Cedars Sinai Medical Center | Los Angeles | California | United States |
| Moffitt Cancer Center | Tampa | Florida | United States |
| Northwestern University | Chicago | Illinois | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Georg-August Universität | Göttingen | Germany |
| Chaim Sheba Medical Center | Tel Litwinsky | Israel |
| VU Medical Center | Amsterdam | Netherlands |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Study stopped early due to slow accrual | Number | participants |
|
| Participants |
|
|
| Secondary | Progression-free Survival | actuarial 2-year PFS | Posted | Number | 95% Confidence Interval | percentage of PARTICIPANTS | 2 years after transplantation |
|
|
|
| Secondary | Clinical Response | complete response (CR) and partial response (PR) proportion at day 100, | Posted | Number | participants | 100 days after transplantation |
|
|
|
| Secondary | Hematopoietic Recovery | time to hematopoietic recovery | Posted | Median | Full Range | DAYS | 100 days after transplantation |
|
|
|
| Secondary | Grade III Toxicity | incidence of infection, grade III-IV toxicities, treatment-related mortality | Posted | Count of Participants | Participants | 100 days after transplantation |
|
|
|
| Secondary | Secondary Malignancies | incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML). | Posted | Count of Participants | Participants | 5 years after transplantation |
|
|
|
| 1 |
| 22 |
| 6 |
| 22 |
| EG001 | Standard BEAM | standard BEAM chemotherapy BEAM chemotherapy and autologous stem-cell transplantation | 0 | 21 | 1 | 21 |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| none |
|