Trial · NCT02703272
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
NCT02703272, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2022-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma. Trials, record NCT02703272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02703272
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
- NCT number
- NCT02703272
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 72 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Ibrutinib, Rituximab, Ifosfamide, Carboplatin, Etoposide, Vincristine, Idarubicin, Dexamethasone
- First posted
- 2016-03-09
- Last updated
- 2022-12-02
- Other registries' IDs
- eudract:2016-000259-28
- Results first posted
- 2022-12-02
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, n (number analyzed) is defined as number of participants analyzed for specified category. | hours*nanogram per milliliter (h*ng/mL) | MEDIAN |
| PRIMARY | Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, n (number analyzed) is defined as number of participants analyzed for specified category. | milliliter per hour (mL/h) | MEDIAN |
| PRIMARY | Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, n (number analyzed) is defined as number of participants analyzed for specified category. | liter(s) | MEDIAN |
| PRIMARY | Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib | Up to Cycle 3 (each cycle of 21 or 28 days) | PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, n (number analyzed) is defined as number of participants analyzed for specified category. | nanograms per milliliter (ng/mL) | MEDIAN |
| PRIMARY | Part 1: Relationship Between AUC and Body Size | Up to Cycle 3 (each cycle of 28 days) | PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib. | ||
| 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) | The intent-to-treat (ITT) population consisted of all randomized participants; participants analyzed based on randomization, regardless of study drug received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Months | MEDIAN |
| 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 | Safety population consisted of all participants who received at least 1 dose of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and Part 2: Overall Response Rate (ORR) | Up to 4 year and 4 months | The ITT Population consisted of all randomized participants; participants analyzed based on randomization, regardless of study drug received. | Percentage of participants | NUMBER |
| SECONDARY | Part 1 and Part 2: Gene Expression Evaluated by Disease-specific Biomarkers at Baseline | Baseline | Biomarker analyses were conducted on the ITT population. As per change in planned analysis, genetic analysis was not performed for Part 1. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Transcripts per million | MEAN |
| 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 | Biomarker analyses were conducted on the ITT population. As per change in planned analysis, immunoglobulin and T-cell receptor gene rearrangements were not performed for Part 1 and Part 2. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 240 mg/m^2 | 1-5 years | 143 | Full Range 116 to 170 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 329 mg/m^2 | 1-5 years | 386 | Full Range 386 to 386 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 440 mg/m^2 | 1-5 years | 310 | Full Range 230 to 543 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 240 mg/m^2 | 6-11 years | 145 | Full Range 140 to 233 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 329 mg/m^2 | 6-11 years | 349 | Full Range 238 to 562 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 440 mg/m^2 | 6-11 years | 324 | Full Range 185 to 538 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 240 mg/m^2 | 12-17 years | 1210 | Full Range 939 to 1450 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib | Part 1: Ibrutinib: 329 mg/m^2 | 12-17 years | 661 | Full Range 394 to 778 | hours*nanogram per milliliter (h*ng/mL) |
| Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib | Part 1: Ibrutinib: 240 mg/m^2 | 1-5 years | 1220 | Full Range 1000 to 1430 | milliliter per hour (mL/h) |
| Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib | Part 1: Ibrutinib: 329 mg/m^2 | 1-5 years | 508 | Full Range 508 to 508 | milliliter per hour (mL/h) |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Ibrutinib+RICE | 11 | |
| Overall Study | STARTED | Part 1: Ibrutinib+RVICI | 10 | |
| Overall Study | STARTED | Part 2: Ibrutinib+CIT (RICE or RVICI) | 35 | |
| Overall Study | STARTED | Part 2: Chemoimmunotherapy | 16 | |
| Overall Study | COMPLETED | Part 1: Ibrutinib+RICE | 0 | |
| Overall Study | COMPLETED | Part 1: Ibrutinib+RVICI | 0 | |
| Overall Study | COMPLETED | Part 2: Ibrutinib+CIT (RICE or RVICI) | 0 | |
| Overall Study | COMPLETED | Part 2: Chemoimmunotherapy | 0 | |
| Overall Study | NOT COMPLETED | Part 1: Ibrutinib+RICE | 11 | |
| Overall Study | NOT COMPLETED | Part 1: Ibrutinib+RVICI | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,100
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 | Anaemia | Blood and lymphatic system disorders | Part 1: Ibrutinib+RICE | 8 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Ibrutinib+RVICI | 9 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Ibrutinib+CIT (RICE or RVICI) | 29 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Chemoimmunotherapy | 14 | 15 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Part 1: Ibrutinib+RICE | 0 | 11 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Part 1: Ibrutinib+RVICI | 1 | 10 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Part 2: Ibrutinib+CIT (RICE or RVICI) | 2 | 35 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Part 2: Chemoimmunotherapy | 0 | 15 | |
| other | Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | Part 1: Ibrutinib+RICE | 0 | 11 | |
| other | Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | Part 1: Ibrutinib+RVICI | 0 | 10 |
1 to 10 of 1,100Source ClinicalTrials.gov
See all 1,100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Ibrutinib+RICE | 4 | 11 |
| Total, all-cause mortality | Part 1: Ibrutinib+RVICI | 9 | 10 |
| Total, all-cause mortality | Part 2: Ibrutinib+CIT (RICE or RVICI) | 19 | 35 |
| Total, all-cause mortality | Part 2: Chemoimmunotherapy | 10 | 15 |
| Total, other adverse events | Part 1: Ibrutinib+RICE | 11 | 11 |
| Total, other adverse events | Part 1: Ibrutinib+RVICI | 10 | 10 |
| Total, other adverse events | Part 2: Ibrutinib+CIT (RICE or RVICI) | 35 | 35 |
| Total, other adverse events | Part 2: Chemoimmunotherapy | 15 | 15 |
| Total, serious adverse events | Part 1: Ibrutinib+RICE | 10 | 11 |
| Total, serious adverse events | Part 1: Ibrutinib+RVICI | 9 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 2: Ibrutinib+CIT (RICE or RVICI) vs Part 2: Chemoimmunotherapy: Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation | Trial comparisons |
| Part 1: Ibrutinib vs Part 2: Ibrutinib: Part 1 and Part 2: Number of Participants With Greater Than (>) 90% Bruton's Tyrosine Kinase (BTK) Occupancy | Trial comparisons |
| Part 2: Ibrutinib+CIT (RICE or RVICI) vs Part 2: Chemoimmunotherapy: Part 2: Number of Participants With c-MYC Gene Rearrangement | Trial comparisons |
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/NCT02703272
GET https://conductscience.org/api/trials/v1/NCT02703272/registered?page=2