Trial · NCT03088878
A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies
NCT03088878, Phase 1, Phase 2, Completed, Oncternal Therapeutics, Inc; results first posted 2025-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies. Trials, record NCT03088878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03088878
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies
- NCT number
- NCT03088878
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- Oncternal Therapeutics, Inc
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- Interventions
- Cirmtuzumab (2-16 kg/mg) plus Ibrutinib, Cirmtuzumab (300mg) plus Ibrutinib, Cirmtuzumab (600 mg) plus ibrutinib, Cirmtuzumab (RDR) plus ibrutinib, Cirmtuzumab plus ibrutinib, Ibrutinib alone
- First posted
- 2017-03-23
- Last updated
- 2025-02-12
- Results first posted
- 2025-02-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response | up to 5 years | Defined as achievement of complete response (CR), complete response with incomplete blood count recovery (CRi), partial response (PR), or partial response with lymphocytosis (PR-L) for those with CLL/SLL, per standardized criteria \[Hallek 2008\], as recently updated \[Hallek 2018; Cheson 2012\]; and the achievement of a CR or PR for those with MCL or MZL, per based on standardized criteria \[Cheson 2007\] as recently updated \[Cheson 2014\]. |
| Secondary | Progression Free Survival (PFS) | Up to 5 years | Defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier Survival Methods. |
| Secondary | Overall Survival | Up to 5 years | Defined as the interval from the start of study therapy to death from any cause. Overall Survival was analyzed using Kaplan-Meier Survival methods. |
| Secondary | Duration of Response | Up to 5 years | Defined as the amount of time (months) for achieving of complete response (CR), complete response with incomplete blood count recovery (CRi), partial response (PR), or partial response with lymphocytosis (PR-L) for those with CLL/SLL; and the amount of time (months) for achieving of a CR or PR for those with MCL. |
| Secondary | Progression-free Survival (PFS) for Patients With TP53 Mutation Status | Up to 5 years | Defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression or death from any cause, in patients with TP53 mutation status |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response | up to 5 years | The efficacy population consists of enrolled subjects who have received at least one dose of either cirmtuzumab or ibrutinib and at least one tumor assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to 5 years | The efficacy population consists of enrolled subjects who have received at least one dose of either cirmtuzumab or ibrutinib and at least one tumor assessment. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 5 years | The efficacy population consists of enrolled subjects who have received at least one dose of either cirmtuzumab or ibrutinib and at least one tumor assessment. | months | MEDIAN |
| SECONDARY | Duration of Response | Up to 5 years | The subset of the efficacy population achieving Objective Response (ORR). The efficacy population consists of enrolled subjects who have received at least one dose of either cirmtuzumab or ibrutinib and at least one tumor assessment. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) for Patients With TP53 Mutation Status | Up to 5 years | A subset of the efficacy population with a positive Del(17p) mutation. The efficacy population consists of enrolled subjects who have received at least one dose of either cirmtuzumab or ibrutinib and at least one tumor assessment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response | MCL Phase 1b, Part 1: 2mg/kg | 3 | Participants | ||
| Overall Response | MCL Phase 1b, Part 1: 4mg/kg | 3 | Participants | ||
| Overall Response | MCL Phase 1b, Part 1: 8mg/kg | 3 | Participants | ||
| Overall Response | MCL Phase 1b, Part 1: 16 mg/kg | 2 | Participants | ||
| Overall Response | MCL Phase 1b, Part 2: 600 mg | 14 | Participants | ||
| Overall Response | CLL Phase 1b, Part 1: 2 mg/kg | 3 | Participants | ||
| Overall Response | CLL Phase 1b, Part 1: 4 mg/kg | 3 | Participants | ||
| Overall Response | CLL Phase 1b, Part 1: 8 mg/kg | 2 | Participants | ||
| Overall Response | CLL Phase 1b, Part 1: 16 mg/kg | 3 | Participants | ||
| Overall Response | CLL Phase 1b, Part 1: 300 mg | 3 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MCL Phase 1b, Part 1: 2mg/kg | 3 | |
| Overall Study | STARTED | MCL Phase 1b, Part 1: 4mg/kg | 3 | |
| Overall Study | STARTED | MCL Phase 1b, Part 1: 8mg/kg | 3 | |
| Overall Study | STARTED | MCL Phase 1b, Part 1: 16 mg/kg | 3 | |
| Overall Study | STARTED | MCL Phase 1b, Part 2: 600 mg | 21 | |
| Overall Study | STARTED | CLL Phase 1b, Part 1: 2 mg/kg | 3 | |
| Overall Study | STARTED | CLL Phase 1b, Part 1: 4 mg/kg | 3 | |
| Overall Study | STARTED | CLL Phase 1b, Part 1: 8 mg/kg | 3 | |
| Overall Study | STARTED | CLL Phase 1b, Part 1: 16 mg/kg | 3 | |
| Overall Study | STARTED | CLL Phase 1b, Part 1: 300 mg | 3 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events924
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 | MCL Phase 1b, Part 1: 2mg/kg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | MCL Phase 1b, Part 1: 4mg/kg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | MCL Phase 1b, Part 1: 8mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MCL Phase 1b, Part 1: 16 mg/kg | 2 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | MCL Phase 1b, Part 2: 600 mg | 6 | 21 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | CLL Phase 1b, Part 1: 2 mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | CLL Phase 1b, Part 1: 4 mg/kg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | CLL Phase 1b, Part 1: 8 mg/kg | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | CLL Phase 1b, Part 1: 16 mg/kg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | CLL Phase 1b, Part 1: 300 mg | 1 | 3 | 2 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MCL Phase 1b, Part 1: 2mg/kg | 0 | 3 |
| Total, all-cause mortality | MCL Phase 1b, Part 1: 4mg/kg | 1 | 3 |
| Total, all-cause mortality | MCL Phase 1b, Part 1: 8mg/kg | 3 | 3 |
| Total, all-cause mortality | MCL Phase 1b, Part 1: 16 mg/kg | 1 | 3 |
| Total, all-cause mortality | MCL Phase 1b, Part 2: 600 mg | 7 | 21 |
| Total, all-cause mortality | CLL Phase 1b, Part 1: 2 mg/kg | 1 | 3 |
| Total, all-cause mortality | CLL Phase 1b, Part 1: 4 mg/kg | 0 | 3 |
| Total, all-cause mortality | CLL Phase 1b, Part 1: 8 mg/kg | 1 | 3 |
| Total, all-cause mortality | CLL Phase 1b, Part 1: 16 mg/kg | 0 | 3 |
| Total, all-cause mortality | CLL Phase 1b, Part 1: 300 mg | 1 | 3 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers4
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 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/NCT03088878
GET https://conductscience.org/api/trials/v1/NCT03088878/results?page=2