Trial · NCT02339922
Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma
NCT02339922, Phase 2, Active not recruiting, University of Washington; results first posted 2026-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma. Trials, record NCT02339922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02339922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma
- NCT number
- NCT02339922
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Chronic Lymphocytic Leukemia, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia
- Interventions
- Ixazomib Citrate, Laboratory Biomarker Analysis, Rituximab
- First posted
- 2015-01-16
- Last updated
- 2026-07-01
- Results first posted
- 2026-03-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Up to 5 years | ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived. |
| Primary | ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL) | Up to 5 years | ORR will be calculated for all treated patients for each disease cohort. The corresponding 95% two-sided confidence interval will be derived. |
| Secondary | Duration of Response (DOR) | From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years | DOR will be calculated to determine durability. Non-responders will be excluded from the analysis of DOR. Kaplan Meier methodology will be used to estimate event-free curves. |
| Secondary | Progression-free Survival (PFS) | Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years | Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves. |
| Secondary | Overall Survival | Up to 5 years | |
| Secondary | CR Rate | Up to 5 years | |
| Secondary | Time to Next Therapy (TNT) | From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years | Data for subjects that have not received additional anti-neoplastic therapy will be censored at the date of last known contact. |
| Secondary | Incidence of Adverse Events (AEs) | Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug. AE's requiring discontinuation of the study drug will be summarized separately, both overall and by AE severity and by relationship to the study drug. Clinically significant abnormal laboratory values will be summarized over study visits. |
| Other | Identification of Clinical Features (i.e. Mantle Cell International Prognostic Score, Follicular Lymphoma International Prognostic Index Score, and International Prognostic Scoring System Score) and Biomarker Expression Levels | Up to 5 years | |
| Other | Single Nucleotide Profile (SNP) Genotyping for PSMB1 P11A | Up to 5 years | SNP genotyping for PSMB1 P11A will be performed and will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL) | Up to 5 years | No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years | No patients with CLL/SLL or WM/LPL met criteria to be included in DOR. | months | MEAN |
| SECONDARY | Progression-free Survival (PFS) | Time from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years | No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 5 years | No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CR Rate | Up to 5 years | No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Next Therapy (TNT) | From the time of first study drug administration until the date of subsequent the first subsequent therapy given to treat the B-NHL, assessed up to 5 years | No patients with Waldenstrom macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL) were enrolled. | months | MEAN |
| SECONDARY | Incidence of Adverse Events (AEs) | Up to 30 days after administration of the last dose of ixazomib citrate (Up to 6 years and 7 months). | AE data was intended to be assessed and reported as a single combined group for this study. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Identification of Clinical Features (i.e. Mantle Cell International Prognostic Score, Follicular Lymphoma International Prognostic Index Score, and International Prognostic Scoring System Score) and Biomarker Expression Levels | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Single Nucleotide Profile (SNP) Genotyping for PSMB1 P11A | Up to 5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL | 0 | Participants | ||
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Treatment (Ixazomib Citrate, Rituximab) for FL | 13 | Participants | ||
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Treatment (Ixazomib Citrate, Rituximab) for MZL | 2 | Participants | ||
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) | Treatment (Ixazomib Citrate, Rituximab) for MCL | 2 | Participants | ||
| ORR (CR + Very Good PR + PR + Minor Response) in Patients With Waldenstrom Macroglobulinemia (WM)/ Lymphoplasmacytic Lymphoma (LPL) | Treatment (Ixazomib Citrate, Rituximab) | 0 | Participants | ||
| Duration of Response (DOR) | Treatment (Ixazomib Citrate, Rituximab) for FL | 42 | Full Range 1 to 60 | months | |
| Duration of Response (DOR) | Treatment (Ixazomib Citrate, Rituximab) for MZL | 35 | Full Range 10 to 60 | months | |
| Duration of Response (DOR) | Treatment (Ixazomib Citrate, Rituximab) for MCL | 60 | Full Range 60 to 60 | months | |
| Progression-free Survival (PFS) | Treatment (Ixazomib Citrate, Rituximab) for CLL/SLL | 1 | Participants | ||
| Progression-free Survival (PFS) | Treatment (Ixazomib Citrate, Rituximab) for FL | 9 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ixazomib Citrate, Rituximab) | 33 | |
| Overall Study | Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) | Treatment (Ixazomib Citrate, Rituximab) | 2 | |
| Overall Study | Follicular lymphoma (FL) | Treatment (Ixazomib Citrate, Rituximab) | 21 | |
| Overall Study | Marginal zone lymphoma (MZL) | Treatment (Ixazomib Citrate, Rituximab) | 6 | |
| Overall Study | Mantle cell lymphoma (MCL) | Treatment (Ixazomib Citrate, Rituximab) | 4 | |
| Overall Study | Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) | Treatment (Ixazomib Citrate, Rituximab) | 0 | |
| Overall Study | COMPLETED | Treatment (Ixazomib Citrate, Rituximab) | 5 | |
| Overall Study | NOT COMPLETED | Treatment (Ixazomib Citrate, Rituximab) | 28 |
Source ClinicalTrials.gov
Adverse events188
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Ixazomib Citrate, Rituximab) | 5 | 33 | 9 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Ixazomib Citrate, Rituximab) | 5 | 33 | 13 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Ixazomib Citrate, Rituximab) | 1 | 33 | 1 |
| other | Allergic reaction | Immune system disorders | Treatment (Ixazomib Citrate, Rituximab) | 1 | 33 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Ixazomib Citrate, Rituximab) | 3 | 33 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Ixazomib Citrate, Rituximab) | 4 | 33 | 7 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Ixazomib Citrate, Rituximab) | 8 | 33 | 8 |
| other | Anxiety | Psychiatric disorders | Treatment (Ixazomib Citrate, Rituximab) | 1 | 33 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Ixazomib Citrate, Rituximab) | 6 | 33 | 6 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Treatment (Ixazomib Citrate, Rituximab) | 1 | 33 | 2 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ixazomib Citrate, Rituximab) | 5 | 33 |
| Total, other adverse events | Treatment (Ixazomib Citrate, Rituximab) | 31 | 33 |
| Total, serious adverse events | Treatment (Ixazomib Citrate, Rituximab) | 4 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36385536 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source 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/NCT02339922
GET https://conductscience.org/api/trials/v1/NCT02339922/results?page=2