Trial · NCT00695409
Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma
NCT00695409, Phase 2, Completed, City of Hope Medical Center; results first posted 2018-07-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma. Trials, record NCT00695409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00695409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma
- NCT number
- NCT00695409
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Lymphoma
- Interventions
- rituximab, carmustine, cytarabine, etoposide, melphalan, ASCT, yttrium Y 90 ibritumomab tiuxetan
- First posted
- 2008-06-11
- Last updated
- 2018-07-06
- Results first posted
- 2018-07-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-Year Progression-Free Survival | From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years | Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\] |
| Secondary | 2-Year Overall Survival | From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years | Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\] |
| Secondary | 2-Year Cumulative Incidence of Progression | From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 years | The cumulative incidence was estimated after taking into account the competing risk of early death. |
| Secondary | Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT | Up to Day 100 post-ASCT | Responses are assessed using the Revised Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al. 2007). Complete Response (CR) defined as disappearance of all evidence of disease. Partial Response (PR) defined as regression of measurable disease and no new sites. |
| Secondary | Number of Patients With Grade 3-4 Bearman Toxicities. | From initial of study treatment to Day 100 post-ASCT | Toxicities were recorded using the modified Bearman Scale for non-hematologic adverse events. |
| Secondary | 100-Day Treatment-Related Mortality | From peripheral stem cell infusion (Day0 ASCT) to death due to any couse, assessed up to 5 years | The cumulative incidence was estimated after taking into account the competing risk of relapse post-ASCT. |
| Secondary | Time to Neutrophil Recovery | From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.) | Neutrophil recovery was defined as the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL. |
| Secondary | Time to Platelet Recovery | From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions | Platelet recovery was defined as the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions. |
| Secondary | Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML | From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 years | Patient receiving the full treatment of RIT/ZBEAM developed therapy induced MDS or AML. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 2-Year Progression-Free Survival | From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years | 6 patients did not receive full treatment so are excluded from the result analysis. | Percentage of Participants (%) | NUMBER |
| SECONDARY | 2-Year Overall Survival | From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years | 6 patients did not receive full treatment so are excluded from the result analysis. | Percentage of Participants (%) | NUMBER |
| SECONDARY | 2-Year Cumulative Incidence of Progression | From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 years | 6 patients did not receive full treatment so are excluded from the result analysis | Percentage of Participants (%) | NUMBER |
| SECONDARY | Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT | Up to Day 100 post-ASCT | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Grade 3-4 Bearman Toxicities. | From initial of study treatment to Day 100 post-ASCT | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 100-Day Treatment-Related Mortality | From peripheral stem cell infusion (Day0 ASCT) to death due to any couse, assessed up to 5 years | 6 patients did not receive full treatment so are excluded from the result analysis. | Percentage of Participants (%) | NUMBER |
| SECONDARY | Time to Neutrophil Recovery | From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.) | 6 patients did not receive full treatment so are excluded from the result analysis. | Days | MEDIAN |
| SECONDARY | Time to Platelet Recovery | From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions | 6 patients did not receive full treatment so are excluded from the result analysis. | Days | MEDIAN |
| SECONDARY | Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML | From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 years | 6 patients did not receive full treatment so are excluded from the result analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 2-Year Progression-Free Survival | Treatment (RIT, ZBEAM, ASCT) | 71 | 95% Confidence Interval 61 to 78 | Percentage of Participants (%) | |
| 2-Year Overall Survival | Treatment (RIT, ZBEAM, ASCT) | 89 | 95% Confidence Interval 82 to 94 | Percentage of Participants (%) | |
| 2-Year Cumulative Incidence of Progression | Treatment (RIT, ZBEAM, ASCT) | 28 | 95% Confidence Interval 20 to 37 | Percentage of Participants (%) | |
| Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT | Patients With Active Disease at ASCT | 53 | Participants | ||
| Number of Patients With Grade 3-4 Bearman Toxicities. | Treatment (RIT, ZBEAM, ASCT) | Gastrointestinal Toxicity | 1 | Participants | |
| Number of Patients With Grade 3-4 Bearman Toxicities. | Treatment (RIT, ZBEAM, ASCT) | Pulmonary Toxicity | 1 | Participants | |
| Number of Patients With Grade 3-4 Bearman Toxicities. | Treatment (RIT, ZBEAM, ASCT) | No Grade 3-4 Toxicity | 120 | Participants | |
| 100-Day Treatment-Related Mortality | Treatment (RIT, ZBEAM, ASCT) | 0.9 | 95% Confidence Interval 0.1 to 6.1 | Percentage of Participants (%) | |
| Time to Neutrophil Recovery | Treatment (RIT, ZBEAM, ASCT) | 10 | 95% Confidence Interval 9 to 13 | Days | |
| Time to Platelet Recovery | Treatment (RIT, ZBEAM, ASCT) | 12 | 95% Confidence Interval 8 to 86 | Days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (RIT, ZBEAM, ASCT) | 122 | |
| Overall Study | COMPLETED | Treatment (RIT, ZBEAM, ASCT) | 122 | |
| Overall Study | NOT COMPLETED | Treatment (RIT, ZBEAM, ASCT) | 0 |
Source ClinicalTrials.gov
Adverse events197
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood/Bone Marrow - Other (Specify, __) | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 2 | 121 | 2 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 11 | 121 | 11 |
| other | Hemoglobin | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 119 | 121 | 119 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 117 | 121 | 130 |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 118 | 121 | 129 |
| other | Myelodysplasia | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 1 | 121 | 1 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 115 | 121 | 154 |
| other | Phlebitis (including superficial thrombosis) | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 1 | 121 | 1 |
| other | Platelets | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 115 | 121 | 121 |
| other | Thrombosis/embolism (vascular access-related) | Blood and lymphatic system disorders | Treatment (RIT, ZBEAM, ASCT) | 1 | 121 | 1 |
1 to 10 of 197Source ClinicalTrials.gov
See all 197 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (RIT, ZBEAM, ASCT) | 25 | 122 |
| Total, other adverse events | Treatment (RIT, ZBEAM, ASCT) | 121 | 122 |
| Total, serious adverse events | Treatment (RIT, ZBEAM, ASCT) | 2 | 122 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P01CA030206 | Hematopoietic Cell Transplantation for Hematologic Malignancies | FORMAN, STEPHEN J | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2010 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00695409
GET https://conductscience.org/api/trials/v1/NCT00695409/events?page=2