Trial · NCT02481297
Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
NCT02481297, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients. Trials, record NCT02481297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02481297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
- NCT number
- NCT02481297
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia
- Interventions
- Lirilumab, Rituximab
- First posted
- 2015-06-25
- Last updated
- 2020-05-28
- Results first posted
- 2020-05-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With a Response | 6 months | Response is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi) or partial remission (PR) that occurs during the first 6 months of therapy. CR requires the absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts. CRi is Complete remission with incomplete bone marrow recovery. PR, defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts |
| Secondary | Overall Survival | Up to 4 years | Time from date of treatment start until date of death due to any cause or last Follow-up. |
| Secondary | Progression Free Survival | Up to 4 years | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With a Response | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 4 years | Months | MEDIAN | |
| SECONDARY | Progression Free Survival | Up to 4 years | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With a Response | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | Participants | ||
| Participants With a Response | Cohort 2: Untreated With High-rRisk mMolecular Features | 3 | Participants | ||
| Overall Survival | Cohort 1: Refractory/Relapsed After Prior Therapy | 6.3 | Months | ||
| Overall Survival | Cohort 2: Untreated With High-rRisk mMolecular Features | 43.6 | Full Range 30.7 to 48.1 | Months | |
| Progression Free Survival | Cohort 1: Refractory/Relapsed After Prior Therapy | 6.3 | Months | ||
| Progression Free Survival | Cohort 2: Untreated With High-rRisk mMolecular Features | 43.6 | Full Range 30.7 to 48.1 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Refractory/Relapsed After Prior Therapy | 1 | |
| Overall Study | STARTED | Cohort 2: Untreated With High-rRisk mMolecular Features | 6 | |
| Overall Study | COMPLETED | Cohort 1: Refractory/Relapsed After Prior Therapy | 1 | |
| Overall Study | COMPLETED | Cohort 2: Untreated With High-rRisk mMolecular Features | 6 | |
| Overall Study | NOT COMPLETED | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: Untreated With High-rRisk mMolecular Features | 0 |
Source ClinicalTrials.gov
Adverse events38
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 | 1 |
| other | Chills | General disorders | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 | 0 |
| other | Chills | General disorders | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 | 1 |
| other | Cough | General disorders | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 | 0 |
| other | Cough | General disorders | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 | 1 |
| other | Edema | General disorders | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 | 0 |
| other | Edema | General disorders | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 | 1 |
| other | Elevated Blood Pressure | Vascular disorders | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 | 0 |
| other | Elevated Blood Pressure | Vascular disorders | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 | 1 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Refractory/Relapsed After Prior Therapy | 0 | 1 |
| Total, all-cause mortality | Cohort 2: Untreated With High-rRisk mMolecular Features | 1 | 6 |
| Total, other adverse events | Cohort 1: Refractory/Relapsed After Prior Therapy | 1 | 1 |
| Total, other adverse events | Cohort 2: Untreated With High-rRisk mMolecular Features | 6 | 6 |
| Total, serious adverse events | Cohort 1: Refractory/Relapsed After Prior Therapy | 1 | 1 |
| Total, serious adverse events | Cohort 2: Untreated With High-rRisk mMolecular Features | 2 | 6 |
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 |
|---|---|
| Cohort 1: Refractory/Relapsed After Prior Therapy vs Cohort 2: Untreated With High-rRisk mMolecular Features: deaths from any cause | Trial comparisons |
| Cohort 1: Refractory/Relapsed After Prior Therapy vs Cohort 2: Untreated With High-rRisk mMolecular Features: Participants With a Response | Trial comparisons |
| Cohort 1: Refractory/Relapsed After Prior Therapy vs Cohort 2: Untreated With High-rRisk mMolecular Features: 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.
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/NCT02481297
GET https://conductscience.org/api/trials/v1/NCT02481297/events?page=2