Trial · NCT02401048
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
NCT02401048, Phase 1, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2019-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas. Trials, record NCT02401048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02401048
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
- NCT number
- NCT02401048
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
- Interventions
- Ibrutinib, MEDI4736
- First posted
- 2015-03-27
- Last updated
- 2019-06-27
- Results first posted
- 2019-06-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b/2 : Overall Response Rate of Number of Participants | From the date of first study treatment until progressive disease | The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014). |
| Secondary | Phase 1b/ 2: Duration of Response | Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first. | |
| Secondary | Phase 1b/ 2: Progression-free Survival (PFS) | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression | |
| Secondary | Phase 1b/2: Overall Survival | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause | |
| Secondary | Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | Peak plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) |
| Secondary | Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Cycle 6 Day 1 (predose) | Trough plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b/2 : Overall Response Rate of Number of Participants | From the date of first study treatment until progressive disease | While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b/ 2: Duration of Response | Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first. | Months | MEDIAN | |
| SECONDARY | Phase 1b/ 2: Progression-free Survival (PFS) | first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression | Months | MEDIAN | |
| SECONDARY | Phase 1b/2: Overall Survival | First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause | Months | MEDIAN | |
| SECONDARY | Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | hour | MEDIAN |
| SECONDARY | Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | ng*h/mL | MEAN |
| SECONDARY | Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib | Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. | hour | MEAN |
| SECONDARY | Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736 | Cycle 6 Day 1 (collected 10 minutes after end of infusion) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736 | Cycle 6 Day 1 (predose) | All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately. | ug/mL | GEOMETRIC_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b/2 : Overall Response Rate of Number of Participants | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 7 | Participants | ||
| Phase 1b/2 : Overall Response Rate of Number of Participants | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 8 | Participants | ||
| Phase 1b/ 2: Duration of Response | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 11.3 | 95% Confidence Interval 8.3 to NA | Months | |
| Phase 1b/ 2: Duration of Response | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | NA | 95% Confidence Interval 2.5 to NA | Months | |
| Phase 1b/ 2: Progression-free Survival (PFS) | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 10.2 | 95% Confidence Interval 4.7 to 13.1 | Months | |
| Phase 1b/ 2: Progression-free Survival (PFS) | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 2.6 | 95% Confidence Interval 1.5 to 4.4 | Months | |
| Phase 1b/2: Overall Survival | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | NA | 95% Confidence Interval 23.6 to NA | Months | |
| Phase 1b/2: Overall Survival | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 5.1 | 95% Confidence Interval 3.7 to 10.1 | Months | |
| Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | Lead-In Day 6/7 | 196 | Standard Deviation 245 | ng/mL |
| Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | Lead-In Day 6/7 | 140 | Standard Deviation 117 | ng/mL |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 27 | |
| Overall Study | STARTED | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 34 | |
| Overall Study | COMPLETED | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 5 | |
| Overall Study | COMPLETED | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 4 | |
| Overall Study | NOT COMPLETED | Phase 1b/ 2: Follicular Lymphoma Expansion Cohort | 22 | |
| Overall Study | NOT COMPLETED | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort | 30 |
Source ClinicalTrials.gov
Adverse events222
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 | Neutropenia | Blood and lymphatic system disorders | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 6 | 27 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 11 | 34 | 21 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 4 | 27 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 6 | 34 | 11 |
| other | Increased tendancy to bruise | Blood and lymphatic system disorders | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 5 | 27 | 7 |
| other | Increased tendancy to bruise | Blood and lymphatic system disorders | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 4 | 34 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 0 | 27 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 6 | 34 | 8 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 0 | 27 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 4 | 34 | 7 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 6 | 27 |
| Total, all-cause mortality | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 24 | 34 |
| Total, other adverse events | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 27 | 27 |
| Total, other adverse events | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 33 | 34 |
| Total, serious adverse events | Phase 1b/2: Follicular Lymphoma Expansion Cohort: | 10 | 27 |
| Total, serious adverse events | Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: | 23 | 34 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase 1b/2: Follicular Lymphoma Expansion Cohort: vs Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort:: deaths from any cause | Trial comparisons |
| Phase 1b/ 2: Follicular Lymphoma Expansion Cohort vs Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort: Phase 1b/2 : Overall Response Rate of Number of Participants | Trial comparisons |
| Phase 1b/2: Follicular Lymphoma Expansion Cohort: vs Phase 1b/ 2: Diffuse Large B-cell Lymphoma Expansion Cohort:: serious adverse events | 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.
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