Trial · NCT02339922
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Gene Expression Profiling on Tumor Specimens | Up to 5 years | Will be correlated with response to rituximab. |
| Other | Tumor Expression of Cluster of Differentiation 68, Nuclear Transcription Factor Kappa-B, p65, p27, and Proteasome Subunit, Alpha-type, 5 by Immunohistochemistry | Up to 5 years | Will be correlated with response to ixazomib citrate and ixazomib citrate plus rituximab. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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