Trial · NCT02703272
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square \[mg/m\^2\], 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. |
| Primary | Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 1 were presented per dose group (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. |
| Primary | Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. |
| Primary | Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age group (1-5, 6-11, 12-17 and \>18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. |
| Primary | Part 1: Relationship Between AUC and Body Size | Up to Cycle 3 (each cycle of 28 days) | The relationship between ibrutinib metrics of systemic exposure (AUC) with body size was assessed to determine the impact on AUC which were presented per dose groups (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age groups (1-5, 6-11, 12-17 and \>18 years). The data could not be analyzed in tabular format for this outcome measure as they correspond to a flat regression line in nonlinear mixed effects modeling. |
| Primary | Part 2: Event Free Survival (EFS) Between the 2 Treatment Groups | Time from Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (up to 4 year and 4 months) | EFS was the time interval from randomization to death, disease progression, or lack of complete response (CR) or partial response (PR) after 3 cycles of treatment, whichever occurred first based on blinded independent event review by the Independent Review Committee (IRC). CR was defined as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions, resected residual mass that was pathologically (morphologically) negative for disease, BM and CSF morphologically free of disease with no new lesions by imaging examination. PR was defined as 50 percent (%) decrease in sum of the products of the lesion diameters (SPD) on CT or MRI; fluorodeoxyglucose (FDG)-positron emission tomography (PET) may be positive, no new or progressive disease (PD); morphologic evidence of disease may be present in BM or cerebrospinal fluid (CSF) if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. |
| Secondary | Part 1 and Part 2: Number of Participants With Adverse Events as Measure of Safety and Tolerability | Up to 4 year and 4 months | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Part 1 and Part 2: Overall Response Rate (ORR) | Up to 4 year and 4 months | ORR was defined as the percentage of participants achieving a best overall response of either complete response (CR) (including CR biopsy-negative \[CRb\] and unconfirmed CR \[CRu\]) or partial response (PR) as evaluated by International Pediatric non-Hodgkin lymphoma (NHL) response criteria. CR=disappearance of all disease; CRb=residual mass has no morphologic evidence of disease from limited or core biopsy, with no new lesions by imaging examination; bone marrow (BM) and CSF morphologically free of disease; no new or PD elsewhere, CRu=Residual mass is negative by FDG-PET; no new lesions by imaging examination; BM and CSF morphologically free of disease; no new or PD elsewhere, PR=50% decrease in SPD on CT or MRI; FDG-PET may be positive (deauville score or 4 or 5 with reduced lesional uptake compared with baseline); no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. |
| Secondary | Part 1 and Part 2: Gene Expression Evaluated by Disease-specific Biomarkers at Baseline | Baseline | Tumor formalin-fixed paraffin-embedded (FFPE) samples were taken to evaluate the baseline gene expression by disease-specific biomarkers such as BCL-2L1 (BCL-xl), BIRC2 (cIAP1), Caspase 3 (CASP3), STAT3, and SYK. Transcripts per million (TPM) is a normalization method for RNA-sequencing, which means "for every 1,000,000 RNA molecules in the RNA-sequencing tumor FFPE sample, x came from this gene/transcript. |
| Secondary | Part 1 and Part 2: Number of Participants With Immunoglobulin and T-cell Receptor Gene Rearrangements | At baseline (Cycle 1 Day 1) of Part 1 and 2 | Number of participants with immunoglobulin and T-cell receptor gene rearrangements were reported. |
| Secondary | Part 1 and Part 2: Number of Participants With Greater Than (>) 90% Bruton's Tyrosine Kinase (BTK) Occupancy | Up to 3 months | Number of participants with \>90% BTK occupancy were reported. Blood samples were collected to assess BTK occupancy. |
| Secondary | Part 1 and Part 2: Visual Analog Scale (VAS) Score for Palatability | Day 1 of Cycle 1 and Cycle 3 | Palatability of ibrutinib was measured by using a VAS. The scale is a 5-point visual analog scale incorporating a facial hedonic scale designed to span pediatric ages and levels of participant comprehension with a score range of 1 to 5, where 1 represents best score and 5 is worst palatability. |
| Secondary | Part 1: Number of Participants With CD79B, CARD11, and MYD Mutations | Up to 4 years and 4 months | Number of Participants with CD79B, CARD11, and MYD Mutations were reported. |
| Secondary | Part 2: Number of Participants With CD79B, CARD11, and MYD Mutations | Up to 4 year and 4 months | Number of participants with CD79B, CARD11, and MYD mutations were reported. Blood samples were taken to evaluate the levels of biomarkers such as CD79B, CARD11, and MYD mutations. |
| Secondary | Part 1: Number of Participants With c-MYC Gene Rearrangement | At baseline (Cycle 1 Day 1) | Number of participants with c-MYC gene rearrangement were reported. |
| Secondary | Part 2: Number of Participants With c-MYC Gene Rearrangement | At baseline (Cycle 1 Day 1) | Number of participants with c-MYC gene rearrangement were reported. Blood samples were taken to evaluate the levels of biomarker such as c-MYC Gene rearrangement. |
| Secondary | Part 2: Percentage of Participants Who Achieved Complete Response (CR) | Up to 4 year and 4 months | Complete response rate was defined as the percentage of participants who achieved complete response or complete response with an incomplete marrow recovery (CRi) on or prior to initiation of subsequent anti-leukemic therapy per the IRC assessment. |
| Secondary | Part 2: Percentage of Participants Who Achieved Partial Response (PR) | Up to 4 year and 4 months | Percentage of participants who achieved PR were assessed. PR was defined as 50% decrease in SPD on computed tomography (CT) or magnetic resonance imaging (MRI); FDG-PET may be positive; no new or PD; morphologic evidence of disease may be present in BM or cerebrospinal fluid (CSF) if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. |
| Secondary | Part 2: Tumor Volume Reduction Rate at Day 14 | At Day 14 | The tumor volume reduction rate was defined as percent decrease in the sum of the products of the lesion diameters at Day 14. It was measured as the mean change in the sum of the products of the lesion diameters (SPD) at Day 14. |
| Secondary | Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation | Up to end of the study (Up to 4 year and 4 months) | Number of participants who proceeded to stem cell transplantation were reported. |
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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