Trial · NCT00012298
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT00012298, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma. Trials, record NCT00012298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00012298
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- NCT number
- NCT00012298
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
- Interventions
- rituximab, yttrium Y 90 ibritumomab tiuxetan, indium In 111 ibritumomab tiuxetan, oprelvekin, filgrastim
- First posted
- 2003-01-27
- Last updated
- 2018-08-09
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | At 8 weeks | This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly. \> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event. \> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here. |
| Primary | Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Assessed up to week 24 | Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution. |
| Primary | Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II) | At 3 years | Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated. |
| Secondary | Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I) | At week 12 | Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response. |
| Secondary | Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I) | At week 12 | Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals. |
| Secondary | Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I) | At week 12 | Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times. |
| Secondary | Survival (Phase II) | From registration to death due to any cause, assessed up to 5 years | Estimated using the method of Kaplan-Meier. |
| Secondary | Time to Disease Progression (Phase II) | From registration to the earliest date documentation of>disease progression, assessed up to 5 years | Estimated using the method of Kaplan-Meier. |
| Secondary | Tumor Response Rate (Phase II) | Assessed up to 5 years | Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated. |
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 | Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | At 8 weeks | DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD. | Patients reporting Dose-Limiting Events | NUMBER |
| PRIMARY | Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Assessed up to week 24 | All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis. | participants | NUMBER |
| PRIMARY | Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II) | At 3 years | Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint. | proportion of participants | NUMBER |
| SECONDARY | Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I) | At week 12 | Not collected. Study team decision not to analyze this endpoint. | ||
| SECONDARY | Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I) | At week 12 | Not collected. Study team decision not to analyze this endpoint. | ||
| SECONDARY | Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I) | At week 12 | Not collected. Study team decision not to analyze this endpoint. | ||
| SECONDARY | Survival (Phase II) | From registration to death due to any cause, assessed up to 5 years | Phase II portion of the study. One patient out of the 39 was deemed ineligible and was not included in survival analysis. | years | MEDIAN |
| SECONDARY | Time to Disease Progression (Phase II) | From registration to the earliest date documentation of>disease progression, assessed up to 5 years | All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible. | years | MEDIAN |
| SECONDARY | Tumor Response Rate (Phase II) | Assessed up to 5 years | All eligible phase II patients. One of the 39 phase II patients was deemed ineligible | percentage of patients with response | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 1, Dose Level 1 | 0 | Patients reporting Dose-Limiting Events | ||
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 1, Dose Level 2 | 2 | Patients reporting Dose-Limiting Events | ||
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 2, Dose Level 3 | 0 | Patients reporting Dose-Limiting Events | ||
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 2, Dose Level 4 | 2 | Patients reporting Dose-Limiting Events | ||
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 3, Dose Level 5 | 0 | Patients reporting Dose-Limiting Events | ||
| Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I) | Treatment: Trial 3, Dose Level 6 | 1 | Patients reporting Dose-Limiting Events | ||
| Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Treatment: Trial 1, Dose Level 1 | Grade 3+ Adverse Event | 9 | participants | |
| Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Treatment: Trial 1, Dose Level 2 | Grade 3+ Adverse Event | 6 | participants | |
| Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Treatment: Trial 2, Dose Level 3 | Grade 3+ Adverse Event | 8 | participants | |
| Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) | Treatment: Trial 2, Dose Level 4 | Grade 3+ Adverse Event | 4 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment: Trial 1, Dose Level 1 | 11 | |
| Overall Study | STARTED | Treatment: Trial 1, Dose Level 2 | 7 | |
| Overall Study | STARTED | Treatment: Trial 2, Dose Level 3 | 9 | |
| Overall Study | STARTED | Treatment: Trial 2, Dose Level 4 | 4 | |
| Overall Study | STARTED | Treatment: Trial 3, Dose Level 5 | 5 | |
| Overall Study | STARTED | Treatment: Trial 3, Dose Level 6 | 6 | |
| Overall Study | STARTED | Treatment : Phase II (Dose Level 6) | 39 | |
| Overall Study | COMPLETED | Treatment: Trial 1, Dose Level 1 | 11 | |
| Overall Study | COMPLETED | Treatment: Trial 1, Dose Level 2 | 7 | |
| Overall Study | COMPLETED | Treatment: Trial 2, Dose Level 3 | 9 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events917
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 | Anemia | Blood and lymphatic system disorders | Treatment: Trial 1, Dose Level 1 | 10 | 11 | 93 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Trial 1, Dose Level 2 | 7 | 7 | 90 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Trial 2, Dose Level 3 | 9 | 9 | 57 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Trial 2, Dose Level 4 | 3 | 4 | 51 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Trial 3, Dose Level 5 | 5 | 5 | 33 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Trial 3, Dose Level 6 | 6 | 6 | 72 |
| other | Anemia | Blood and lymphatic system disorders | Treatment : Phase II (Dose Level 6) | 34 | 39 | 330 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment: Trial 1, Dose Level 1 | 0 | 11 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment: Trial 1, Dose Level 2 | 0 | 7 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment: Trial 2, Dose Level 3 | 1 | 9 | 18 |
1 to 10 of 917Source ClinicalTrials.gov
See all 917 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment: Trial 1, Dose Level 1 | ||
| Total, all-cause mortality | Treatment: Trial 1, Dose Level 2 | ||
| Total, all-cause mortality | Treatment: Trial 2, Dose Level 3 | ||
| Total, all-cause mortality | Treatment: Trial 2, Dose Level 4 | ||
| Total, all-cause mortality | Treatment: Trial 3, Dose Level 5 | ||
| Total, all-cause mortality | Treatment: Trial 3, Dose Level 6 | ||
| Total, all-cause mortality | Treatment : Phase II (Dose Level 6) | ||
| Total, other adverse events | Treatment: Trial 1, Dose Level 1 | 11 | 11 |
| Total, other adverse events | Treatment: Trial 1, Dose Level 2 | 7 | 7 |
| Total, other adverse events | Treatment: Trial 2, Dose Level 3 | 9 | 9 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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.
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