Trial · NCT01712659
Ruxolitinib for Adult T-Cell Leukemia
NCT01712659, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2023-01-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Ruxolitinib for Adult T-Cell Leukemia. Trials, record NCT01712659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib for Adult T-Cell Leukemia
- NCT number
- NCT01712659
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- T Cell Leukemia, Adult, Leukemia, Adult T-Cell, T Cell Leukemia, HTLV I Associated
- Interventions
- Ruxolitinib, Ruxolitinib, Ruxolitinib, Ruxolitinib
- First posted
- 2012-10-23
- Last updated
- 2023-01-10
- Results first posted
- 2023-01-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II: Best Response | From the time of the start of treatment to approximately 3 years of 5 | Best response is complete response (CR) plus partial response (PR). Response was measured by the Revised Response Criteria for Lymphoma by Cheson, et al, and the International Consensus Meeting Criteria for Adult T-Cell Lymphoma (ATL). Complete response is disappearance of all clinical, microscopic, and radiographic evidence of disease. Partial response is a ≥50% reduction in the sum of the products of the greatest diameters of measurable disease without the appearance of new lesion. Stable disease is failure to attain complete response, partial response, or progressive disease. Progressive disease in peripheral blood is defined by a 50% increase from nadir in the count of flower cells and an absolute lymphocyte count, including flower cells, of 4x10\^9/L; or the appearance of new lesions excluding skin. |
| Primary | Phase I: Maximum Tolerated Dose (MTD) | From the time of the start of treatment to approximately 1 year | MTD is defined as the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the first cycle (28 days) treatment, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. A DLT is any grade 3 or 4 toxicity, if deemed possibly, probably, or definitely related to the study drug by the principal investigator during the first cycle of treatment with some exceptions such as Grade 3 anemia without hemolysis. Grade 3 or 4 granulocytopenia or leukopenia without infection, Grade 3 thrombocytopenia without bleeding, and Grade 3 or 4 lymphopenia. Grade 3 is severe or medically significant. Grade 4 is life-threatening, urgent intervention indicated. |
| Secondary | Phase II: Time to Progression (TTP) | From the time of the start of treatment to approximately 3 years | TTP is defined as the date of protocol consent until date of progressive disease is documented. Progressive disease was assessed by the Revised Response Criteria for Lymphoma by Cheson, et al, and the International Consensus Meeting Criteria for Adult T-Cell Lymphoma (guideline (version 1.1). Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more new lesions. |
| Secondary | Phase II: Survival Time | From the time of the start of treatment to approximately 3 years | Survival time is defined as the date of protocol consent until the date of the subject's death for any cause. |
| Secondary | Phase I: Grade of Serious and/or Non-serious Adverse Events (SAEs) Related to the Experimental Treatment by Grade | From the time of the start of treatment to approximately 1 year | Grade of serious adverse events (SAEs) related to the experimental treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening. |
| Secondary | Phase I: Time to Progression When Ruxolitinib is Administered at Doses of 30, 40 or 50 mg Orally Twice Daily | From the time of the start of treatment to approximately 1 year | TTP is defined as the date of protocol consent until date of progressive disease is documented. Progressive disease was assessed by the Revised Response Criteria for Lymphoma by Cheson, et al, and the International Consensus Meeting Criteria for Adult T-Cell Lymphoma guidelines (version 1.1). Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more new lesions. |
| Other | Number of Participants With a Dose Limiting Toxicity (DLT) | During the first cycle of treatment (28 days) | A DLT is any grade 3 or 4 toxicity, if deemed possibly, probably or definitely related to the study drug by the principal investigator during the first cycle of treatment with some exceptions such as Grade 3 anemia without hemolysis. Grade 3 or 4 granulocytopenia or leukopenia without infection, Grade 3 thrombocytopenia without bleeding, and Grade 3 or 4 lymphopenia. Grade 3 is severe or medically significant. Grade 4 is life-threatening, urgent intervention indicated. |
| Other | Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 110 months and 27 days. | Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase II: Best Response | From the time of the start of treatment to approximately 3 years of 5 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase I: Maximum Tolerated Dose (MTD) | From the time of the start of treatment to approximately 1 year | No participants were treated in an expansion cohort (50mg) before the protocol was closed. | mg | NUMBER |
| SECONDARY | Phase II: Time to Progression (TTP) | From the time of the start of treatment to approximately 3 years | Months | MEAN | |
| SECONDARY | Phase II: Survival Time | From the time of the start of treatment to approximately 3 years | Months | MEAN | |
| SECONDARY | Phase I: Grade of Serious and/or Non-serious Adverse Events (SAEs) Related to the Experimental Treatment by Grade | From the time of the start of treatment to approximately 1 year | Adverse Events | NUMBER | |
| SECONDARY | Phase I: Time to Progression When Ruxolitinib is Administered at Doses of 30, 40 or 50 mg Orally Twice Daily | From the time of the start of treatment to approximately 1 year | No participants were enrolled on the expansion cohort for the phase I dose escalation (50mg) version of the protocol. | Months | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose Limiting Toxicity (DLT) | During the first cycle of treatment (28 days) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 110 months and 27 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II: Best Response | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Complete Response | 0 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Complete Response | 0 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Complete Response | 0 | Participants | |
| Phase II: Best Response | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Partial Response | 1 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Partial Response | 1 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Partial Response | 0 | Participants | |
| Phase II: Best Response | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Stable Disease | 6 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Stable Disease | 3 | Participants | |
| Phase II: Best Response | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Stable Disease | 0 | Participants | |
| Phase II: Best Response | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Progressive Disease | 5 | Participants |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 1 | |
| Dose Escalation | STARTED | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 5 | |
| Dose Escalation | STARTED | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 1 | |
| Dose Escalation | STARTED | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily | 0 | |
| Dose Escalation | STARTED | 3- Phase 1 Dose Expansion Cohort | 0 | |
| Dose Escalation | COMPLETED | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 1 | |
| Dose Escalation | COMPLETED | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 3 | |
| Dose Escalation | COMPLETED | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 1 | |
| Dose Escalation | COMPLETED | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily | 0 | |
| Dose Escalation | COMPLETED | 3- Phase 1 Dose Expansion Cohort | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events123
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 | Abdominal pain | Gastrointestinal disorders | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0 | 1 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 1 | 12 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 0 | 6 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0 | 1 | 0 |
| other | Alanine aminotransferase increased | Investigations | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 3 | 12 | 5 |
| other | Alanine aminotransferase increased | Investigations | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2 | 6 | 2 |
| other | Alanine aminotransferase increased | Investigations | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0 | 1 | 0 |
| other | Alkaline phosphatase increased | Investigations | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 1 | 12 | 1 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 11 | 12 |
| Total, all-cause mortality | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 3 | 6 |
| Total, all-cause mortality | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0 | 1 |
| Total, other adverse events | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 12 | 12 |
| Total, other adverse events | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 6 | 6 |
| Total, other adverse events | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 1 | 1 |
| Total, serious adverse events | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 0 | 12 |
| Total, serious adverse events | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 0 | 6 |
| Total, serious adverse events | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0 | 1 |
Source ClinicalTrials.gov
Papers4
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/NCT01712659
GET https://conductscience.org/api/trials/v1/NCT01712659/results?page=2