Trial · NCT04185220
Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome
NCT04185220, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2021-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome. Trials, record NCT04185220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04185220
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome
- NCT number
- NCT04185220
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult T-Cell Lymphoma/Leukemia, Sezary Syndrome, Mycosis Fungoides
- Interventions
- Recombinant human Interleukin-15 (rhIL-15), Mogamulizumab
- First posted
- 2019-12-04
- Last updated
- 2023-01-04
- Results first posted
- 2021-12-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15) | 28 days | The MTD is the dose level at which no more than 1 of up to 6 patients experience DLT during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) patients have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab. |
| Primary | Number of Grade 1-4 Treatment Related Adverse Events | Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2. | Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event. |
| Secondary | Event Free Survival | Up to one year | Event-free survival (EFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. |
| Secondary | Progression-free Survival | Up to one year | Progression-free survival (PFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Progressive Disease (PD) is new or increased lesions. |
| Secondary | Number of Participants Overall Response | 6 cycles (one cycle is 28 days) | Overall response was assessed by the Response Criteria for Adult T-cell Leukemia-Lymphoma. The response rate was determined and reported along with a 95% confidence interval. Complete Response (CR) is disappearance of all disease. Unconfirmed Complete Response (CRu) is stable residual mass in bulky lesion. Partial Response (PR) is regression of disease. Relapsed Disease (RD)/Progressive Disease (PD) is new or increased lesions. And Stable Disease (SD) is failure to attain CR/PR and no PD. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. | First cycle of treatment (28 days) | A DLT is defined as any grade 3 (severe), 4 (life-threatening), or 5 (death related to adverse event) toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15) | 28 days | mcg/kg/day | NUMBER | |
| PRIMARY | Number of Grade 1-4 Treatment Related Adverse Events | Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2. | adverse events | NUMBER | |
| SECONDARY | Event Free Survival | Up to one year | Months | MEAN | |
| SECONDARY | Progression-free Survival | Up to one year | Months | MEAN | |
| SECONDARY | Number of Participants Overall Response | 6 cycles (one cycle is 28 days) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. | First cycle of treatment (28 days) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group103
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15) | All Participants | 2 | mcg/kg/day | ||
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | Grade 1 Alanine aminotransferase increased | 2 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | Grade 1 Alanine aminotransferase increased | 1 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | Grade 1 Aspartate aminotransferase increased | 2 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | Grade 1 Aspartate aminotransferase increased | 1 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | Grade 1 Bronchial infection | 1 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | Grade 1 Bronchial infection | 0 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | Grade 1 Chills | 1 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | Grade 1 Chills | 0 | adverse events | |
| Number of Grade 1-4 Treatment Related Adverse Events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | Grade 1 Diarrhea | 1 | adverse events |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 3 | |
| Dose Escalation | STARTED | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 3 | |
| Dose Escalation | COMPLETED | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 3 | |
| Dose Escalation | COMPLETED | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 1 | |
| Dose Escalation | NOT COMPLETED | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 0 | |
| Dose Escalation | NOT COMPLETED | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 2 | |
| Dose Expansion | STARTED | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 0 | |
| Dose Expansion | STARTED | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 0 | |
| Dose Expansion | COMPLETED | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 0 | |
| Dose Expansion | COMPLETED | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events152
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 | Acute kidney injury | Renal and urinary disorders | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 1 | 3 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 1 | 3 | 4 |
| other | Alanine aminotransferase increased | Investigations | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 1 | 3 | 1 |
| other | Alkaline phosphatase increased | Investigations | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 1 | 3 | 2 |
| other | Alkaline phosphatase increased | Investigations | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 1 | 3 | 18 |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 1 | 3 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 0 | 3 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 1 | 3 | 1 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 2 | 3 |
| Total, all-cause mortality | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 1 | 3 |
| Total, other adverse events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 3 | 3 |
| Total, other adverse events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 3 | 3 |
| Total, serious adverse events | Dose Level 1 (Interleukin-15 2mcg/kg/Day) | 3 | 3 |
| Total, serious adverse events | Dose Level 2 (Interleukin-15 4mcg/kg/Day) | 2 | 3 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Dose Level 1 (Interleukin-15 2mcg/kg/Day) vs Dose Level 2 (Interleukin-15 4mcg/kg/Day): Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Dose Level 1 (Interleukin-15 2mcg/kg/Day) vs Dose Level 2 (Interleukin-15 4mcg/kg/Day): deaths from any cause | Trial comparisons |
| Dose Level 1 (Interleukin-15 2mcg/kg/Day) vs Dose Level 2 (Interleukin-15 4mcg/kg/Day): 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/NCT04185220
GET https://conductscience.org/api/trials/v1/NCT04185220/results?page=2