Trial · NCT03759184
Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
NCT03759184, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2022-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia. Trials, record NCT03759184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03759184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
- NCT number
- NCT03759184
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- rhIL-15, rhIL-15, Obinutuzumab
- First posted
- 2018-11-29
- Last updated
- 2022-03-22
- Results first posted
- 2022-03-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-emergent Adverse Events (AEs) Related to Recombinant Human Interleukin-15 (rhIL-15) | 28 days or 4 weeks (cycle 1) | Here is the number of treatment-emergent AEs related to rhIL-15 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A treatment emergent AE is defined as |
| Primary | Number of Treatment-emergent Adverse Events (AEs) Related to Obinutuzumab | 28 days or 4 weeks (cycle 1) | Here is the number of treatment-emergent AEs related to Obinutuzumab assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A treatment emergent AE is defined as |
| Primary | Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | 28 days or 4 weeks (cycle 1) | A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to interleukin-15 by the principal investigator during the first 28 days of treatment. Some exceptions are grade 3 or 4 lymphocytopenia or neutropenia without clinical signs of infection grade 2 or above, grade 3 or 4 thrombocytopenia lasting fewer than 5 days and not associated with bleeding or purpura. Transient (\<24 hours) grade 3 hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia or hypophosphatemia which responds to medical intervention. Grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event. |
| Primary | Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment | 28 days or 4 weeks (cycle 1) | A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to Obinutuzumab by the principal investigator during the first 28 days of treatment. Some exceptions are grade 3 or 4 lymphocytopenia or neutropenia without clinical signs of infection grade 2 or above, grade 3 or 4 thrombocytopenia lasting fewer than 5 days and not associated with bleeding or purpura. Transient (\<24 hours) grade 3 hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia or hypophosphatemia which responds to medical intervention. Grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event. |
| Primary | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) Administration | 28 days or 4 weeks (cycle 1) | The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose limiting toxicity (DLT) during the DLT evaluation window, or the dose at which at least 2 of ≤ 6 participants have DLT. A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to interleukin-15 by the principal investigator during the first 28 days of treatment. |
| Primary | Maximum Tolerated Dose (MTD) of Intravenous (IV) Obinutuzumab Treatment | 28 days or 4 weeks (cycle 1) | The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose limiting toxicity (DLT) during the DLT evaluation window, or the dose at which at least 2 of ≤ 6 participants have DLT. A DLT is defined as a grade 3-5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably, or definitely related to Obinutuzumab by the principal investigator during the first 28 days of treatment. |
| Secondary | Duration of Response (DOR) | time measurement criteria are met for CR, CRi, or PR whichever is recorded first until the first date that recurrent of progressive disease is objectively documented or death, approximately 27 months | DOR is measured from the time measurement criteria are met for complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) whichever is recorded first until the first date that recurrent of progressive disease is objectively documented, death, or in the absence of progressive disease (PD), date of last assessment. Response was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. Complete response (CR) is disease related constitutional symptoms resolved; partial response (PR) is two criteria from Group A (e.g. lymphadenopathy or liver and/or spleen size) if abnormal at baseline plus one of the criteria from Group B (e.g. platelet count) must be met; complete response with incomplete marrow recovery (CRi) is CR with incomplete hematopoietic recovery; stable disease (SD) is defined as not achieving CR or PR, and PD is development of transformation to a more aggressive histology. |
| Secondary | Overall Response Rate | 6 cycles (each cycle is 28 days or 4 weeks) | Overall response is defined as the best response recorded from the start of the treatment until disease progression/recurrence. OS was estimated using the Kaplan-Meier curves and a 95% confidence interval. Response was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines. Complete response (CR) is disease related constitutional symptoms resolved; Partial response (PR) is two criteria from Group A (e.g. lymphadenopathy or liver and/or spleen size) if abnormal at baseline plus one of the criteria from Group B (e.g. platelet count) must be met, requires the absence of growth factor or transfusion support; Complete response with incomplete marrow recovery (CRi) is CR with incomplete hematopoietic recovery; Stable disease (SD) is defined as not achieving CR or PR, but not fulfilling the criteria for progressive disease (PD); and PD is one criteria from Group A or B are met or development of transformation to a more aggressive histology. |
| Secondary | Event-free Survival (EFS) | Approximately 8 months | EFS is defined as the duration of time from the date of study enrollment until time of disease lapse, disease progression, alternative therapy for lymphoma given, or death, whichever comes first. EFS was estimated using the Kaplan-Meier curves and a 95% confidence interval. Progression was assessed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and is defined as one criterion from Group A (e.g., lymphadenopathy or liver and/or spleen size) or B (e.g., platelet count) are met or development of transformation to a more aggressive histology. |
| Secondary | Overall Survival (OS) | Approximately 27 months | OS is defined as the date of on-study to the date of death from any cause or last follow up. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-emergent Adverse Events (AEs) Related to Recombinant Human Interleukin-15 (rhIL-15) | 28 days or 4 weeks (cycle 1) | adverse events | NUMBER | |
| PRIMARY | Number of Treatment-emergent Adverse Events (AEs) Related to Obinutuzumab | 28 days or 4 weeks (cycle 1) | adverse events | NUMBER | |
| PRIMARY | Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | 28 days or 4 weeks (cycle 1) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Grade 3-5 Dose-limiting Toxicity (DLT) With Intravenous (IV) Obinutuzumab Treatment | 28 days or 4 weeks (cycle 1) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) Administration | 28 days or 4 weeks (cycle 1) | This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled. | ||
| PRIMARY | Maximum Tolerated Dose (MTD) of Intravenous (IV) Obinutuzumab Treatment | 28 days or 4 weeks (cycle 1) | This outcome measure was not done. The MTD was not found because the study was closed after \> 1 year of inactivity and only one participant was enrolled. | ||
| SECONDARY | Duration of Response (DOR) | time measurement criteria are met for CR, CRi, or PR whichever is recorded first until the first date that recurrent of progressive disease is objectively documented or death, approximately 27 months | Months | MEDIAN | |
| SECONDARY | Overall Response Rate | 6 cycles (each cycle is 28 days or 4 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event-free Survival (EFS) | Approximately 8 months | There is no confidence interval with 1 sample result. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Approximately 27 months | There is no full range with 1 sample result. | Months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events (AEs) Related to Recombinant Human Interleukin-15 (rhIL-15) | Arm 1 - Dose Escalation - Dose Level 1 | 0 | adverse events | ||
| Number of Treatment-emergent Adverse Events (AEs) Related to Obinutuzumab | Arm 1 - Dose Escalation - Dose Level 1 | 0 | adverse events | ||
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 3 Possibly Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 3 Probably Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 3 Definitely Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 4 Possibly Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 4 Probably Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 4 Definitely Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 5 Possibly Related | 0 | Participants | |
| Number of Participants With a Grades 3-5 Dose-limiting Toxicity (DLT) of Continuous Intravenous (CIV) Recombinant Human Interleukin-15 (rhIL-15) Treatment | Arm 1 - Dose Escalation - Dose Level 1 | Grade 5 Probably Related | 0 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 - Dose Escalation - Dose Level 1 | 1 | |
| Overall Study | COMPLETED | Arm 1 - Dose Escalation - Dose Level 1 | 1 | |
| Overall Study | NOT COMPLETED | Arm 1 - Dose Escalation - Dose Level 1 | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Constipation | Gastrointestinal disorders | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Fatigue | General disorders | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Fever | General disorders | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 3 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Irritability | Psychiatric disorders | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Neutrophil count decreased | Investigations | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 2 |
| other | Paronychia | Infections and infestations | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| other | Sinusitis | Infections and infestations | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
| serious | Bone infection | Infections and infestations | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 - Dose Escalation - Dose Level 1 | 0 | 1 |
| Total, other adverse events | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 |
| Total, serious adverse events | Arm 1 - Dose Escalation - Dose Level 1 | 1 | 1 |
Source ClinicalTrials.gov
Papers2
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/NCT03759184
GET https://conductscience.org/api/trials/v1/NCT03759184/results?page=2