Trial · NCT02898259
Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma
NCT02898259, Phase 1, Phase 2, Terminated, Brian Hill; results first posted 2021-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma. Trials, record NCT02898259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02898259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide, Ixazomib, and Rituximab as Front-Line Therapy for High Risk Indolent B-Cell Lymphoma
- NCT number
- NCT02898259
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Brian Hill
- Conditions
- B Cell Lymphoma, Lymphoma
- Interventions
- Ixazomib, Lenalidomide, Rituximab
- First posted
- 2016-09-13
- Last updated
- 2022-09-26
- Results first posted
- 2021-01-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Oral Ixazomib | 15 months after beginning treatment | To determine the MTD of the combination of oral ixazomib and lenalidomide plus rituximab in patients with previously untreated low-grade B cell lymphoma having high tumor burden by GELF criteria or FLIPI 3-5. MTD will be determined using the first 12 participants 15 months after beginning treatment |
| Secondary | Overall Response Rate | Up to 15 months after beginning treatment | These criteria are based on the Revised Response Criteria for Malignant Lymphoma and include the following categories: Complete Response (CR)(Complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy), Partial Response (PR) (A ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses), Stable Disease (SD) (Failing to attain the criteria needed for a PR or CR, but not fulfilling those for progressive disease), Relapse and Progression (PD) (For determination of relapsed and progressive disease, lymph nodes should be considered abnormal if the long axis is more than 1.5 cm, regardless of the short axis). |
| Secondary | Duration of Response | Up to 15 months after beginning treatment | Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. |
| Secondary | Time to Progression | Up to 15 months after beginning treatment | Duration of time from start of treatment to time of progression. |
| Secondary | Progression Free Survival | Up to 15 months after beginning treatment | A number of participants who survived without disease progression PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Time to Treatment Failure | Up to 15 months after beginning treatment | Time to treatment failure (event-free survival) is defined as the time from study entry to first event of disease progression, discontinuation of treatment for any reason, initiation of new treatment, or death. |
| Secondary | Overall Survival | Up to 15 months after beginning treatment | Overall survival is defined as the date of study entry to the date of death. |
Source ClinicalTrials.gov
Outcomes7
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 Oral Ixazomib | 15 months after beginning treatment | First 12 participants put on study | mg | NUMBER |
| SECONDARY | Overall Response Rate | Up to 15 months after beginning treatment | Participants who received treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | Up to 15 months after beginning treatment | Participants who received treatment | months | MEDIAN |
| SECONDARY | Time to Progression | Up to 15 months after beginning treatment | Participants who received treatment | months | MEDIAN |
| SECONDARY | Progression Free Survival | Up to 15 months after beginning treatment | Participants who received treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Failure | Up to 15 months after beginning treatment | Participants who received treatment | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 15 months after beginning treatment | Participants who received treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group43
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 Oral Ixazomib | Lenalidomide + Ixazomib + Rituximab | 4 | mg | ||
| Overall Response Rate | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Complete response | 1 | Participants | |
| Overall Response Rate | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Complete response | 2 | Participants | |
| Overall Response Rate | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Complete response | 2 | Participants | |
| Overall Response Rate | Expansion Cohort I: Follicular Lymphoma at MTD | Complete response | 5 | Participants | |
| Overall Response Rate | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | Complete response | 0 | Participants | |
| Overall Response Rate | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Stable Disease | 2 | Participants | |
| Overall Response Rate | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Stable Disease | 0 | Participants | |
| Overall Response Rate | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | Stable Disease | 3 | Participants | |
| Overall Response Rate | Expansion Cohort I: Follicular Lymphoma at MTD | Stable Disease | 0 | Participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 3 | |
| Overall Study | STARTED | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 3 | |
| Overall Study | STARTED | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 6 | |
| Overall Study | STARTED | Expansion Cohort I: Follicular Lymphoma at MTD | 7 | |
| Overall Study | STARTED | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 | |
| Overall Study | COMPLETED | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 2 | |
| Overall Study | COMPLETED | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 2 | |
| Overall Study | COMPLETED | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 1 | |
| Overall Study | COMPLETED | Expansion Cohort I: Follicular Lymphoma at MTD | 6 | |
| Overall Study | COMPLETED | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events415
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 | Rash maculo-papular | Skin and subcutaneous tissue disorders | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 2 | 3 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 2 | 3 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 2 | 6 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Expansion Cohort I: Follicular Lymphoma at MTD | 5 | 6 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 | ||
| other | Rash acneiform | Skin and subcutaneous tissue disorders | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 0 | 3 | |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 1 | 3 | |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 1 | 6 | |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | Expansion Cohort I: Follicular Lymphoma at MTD | 0 | 6 | |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 |
1 to 10 of 415Source ClinicalTrials.gov
See all 415 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 0 | 3 |
| Total, all-cause mortality | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 0 | 3 |
| Total, all-cause mortality | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 0 | 6 |
| Total, all-cause mortality | Expansion Cohort I: Follicular Lymphoma at MTD | 1 | 6 |
| Total, all-cause mortality | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 | 0 |
| Total, other adverse events | DL1 (Ixazomib 2.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 3 | 3 |
| Total, other adverse events | DL2 (Ixazomib 3.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 3 | 3 |
| Total, other adverse events | DL3/MTD (Ixazomib 4.0 mg + Lenalidomide 20 mg + Rituximab 375mg/m2) | 6 | 6 |
| Total, other adverse events | Expansion Cohort I: Follicular Lymphoma at MTD | 6 | 6 |
| Total, other adverse events | Expansion Cohort 2: Non-Follicular Lymphoma at MTD | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
GET https://conductscience.org/api/trials/v1/NCT02898259
GET https://conductscience.org/api/trials/v1/NCT02898259/results?page=2