A Phase 1/2 interventional study of Ruxolitinib and Ruxolitinib in T Cell Leukemia, Adult, Leukemia, Adult T-Cell and T Cell Leukemia, HTLV I Associated, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
Background:
Objectives:
Initial Phase II design:
Subsequent Phase I dose escalation with expansion cohort treated at the MTD or MAD:
Eligibility:
Design:
Background:
Primary Objective:
Objective Initial Phase II:
Eligibility
Design
31 studies on the registry are indexed under Leukemia-Lymphoma, Adult T-Cell; 5 are open to participants now.
This study's enrollment of 19 is below the median of 27 across 26 interventional studies indexed under Leukemia-Lymphoma, Adult T-Cell.
Browse Leukemia-Lymphoma, Adult T-Cell studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE: After approval and activation of Amendment D, subjects who have failed this protocol treatment previously at the initial dose level may be eligible for re-enrollment and retreatment if they otherwise meet eligibility criteria.
EXCLUSION CRITERIA:
Documented active bacterial infections, HTLV-II infection, or or C as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ruxolitinib 20 mg orally twice daily for 28 days. Subjects may continue to receive treatment until progressive disease (PD) or unacceptable toxicity.
Drug: Ruxolitinib
Dose level 1: Ruxolitinib 30 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity. Dose level 2: Ruxolitinib: Ruxolitinib 40 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity. Dose level 3: Ruxolitinib: Ruxolitinib 50 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity.
Drug: Ruxolitinib
Ruxolitinib at the maximum tolerated dose (MTD) or the maximum administered dose (MAD) defined in the phase 1 dose escalation cohorts. Subjects may continue to receive treatment until progressive disease (PD) or unacceptable toxicity.
Drug: Ruxolitinib
Ruxolitinib 20 mg orally twice daily for 28 days. Subjects may continue to receive treatment until progressive disease (PD) or unacceptable toxicity.
Also known as: Jakafi
Ruxolitinib 30 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity.
Also known as: Jakafi
Ruxolitinib: Ruxolitinib 40 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity.
Also known as: Jakafi
Ruxolitinib 50 mg orally twice daily for 28 days to determine the maximum tolerated dose (MTD). Subjects may continue to receive treatment until progressive disease (PD) or dose limiting toxicity (DLT) or unacceptable toxicity.
Also known as: Jakafi
Phase II: Best Response
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.
Time frame: From the time of the start of treatment to approximately 3 years of 5
Phase I: Maximum Tolerated Dose (MTD)
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.
Time frame: From the time of the start of treatment to approximately 1 year
Phase II: Time to Progression (TTP)
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.
Time frame: From the time of the start of treatment to approximately 3 years
Phase II: Survival Time
Survival time is defined as the date of protocol consent until the date of the subject's death for any cause.
Time frame: From the time of the start of treatment to approximately 3 years
Phase I: Grade of Serious and/or Non-serious Adverse Events (SAEs) Related to the Experimental Treatment by Grade
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.
Time frame: From the time of the start of treatment to approximately 1 year
Phase I: Time to Progression When Ruxolitinib is Administered at Doses of 30, 40 or 50 mg Orally Twice Daily
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.
Time frame: From the time of the start of treatment to approximately 1 year
Number of Participants With a Dose Limiting Toxicity (DLT)
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.
Time frame: During the first cycle of treatment (28 days)
Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
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.
Time frame: Date treatment consent signed to date off study, approximately 110 months and 27 days.
| Milestone | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily | 3- Phase 1 Dose Expansion Cohort |
|---|---|---|---|---|---|
| Started | 1 | 5 | 1 | 0 | 0 |
| Completed | 1 | 3 | 1 | 0 | 0 |
| Not completed | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Unable to take study drug | 0 | 1 | 0 | 0 | 0 |
| Milestone | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily | 3- Phase 1 Dose Expansion Cohort |
|---|---|---|---|---|---|
| Started | 12 | 0 | 0 | 0 | 0 |
| Completed | 10 | 0 | 0 | 0 | 0 |
| Not completed | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Early disease progression | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 |
| Milestone | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily | 3- Phase 1 Dose Expansion Cohort |
|---|---|---|---|---|---|
| Started | 0 | 1 | 0 | 0 | 0 |
| Completed | 0 | 1 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| Complete Response | 0 | 0 | 0 |
| Partial Response | 1 | 1 | 0 |
| Stable Disease | 6 | 3 | 0 |
| Progressive Disease | 5 | 0 | 1 |
| Not Assessable | 0 | 2 | 0 |
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.
| mg | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily |
|---|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) | NA | NA | — |
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.
| Months | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| Phase II: Time to Progression (TTP) | 5.25 ± 7.62 | 3.36 ± 3.34 | 1 ± NA |
Survival time is defined as the date of protocol consent until the date of the subject's death for any cause.
| Months | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| Phase II: Survival Time | 29.3 (15.7 to 42.9) | 20.1 (3.9 to 36.3) | 14.1 (NA to NA) |
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.
| Adverse Events | Grade 1 - Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Grade 2 - Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Grade 3 - Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Grade 4 - Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | Grade 1 - 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Grade 2 - Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Grade 3 - Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Grade 4 - Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | Grade 1 - 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Grade 2 - 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Grade 3 - 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Grade 4 - 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Alanine aminotransferase increased | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lymphocyte count decreased | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bilirubin increased | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White blood cells decreased | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Platelet count decreased | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Creatinine increased | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypernatremia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Alkaline phosphatase increased | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
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.
| Months | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 3 - 50 mg Twice Daily |
|---|---|---|---|---|
| Phase I: Time to Progression When Ruxolitinib is Administered at Doses of 30, 40 or 50 mg Orally Twice Daily | 5.2 (0.89 to 9.51) | 4.1 (0.77 to 7.43) | 1 (NA to NA) | — |
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.
| Participants | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| Number of Participants With a Dose Limiting Toxicity (DLT) | 0 | 0 | 0 |
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.
| Participants | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | 12 | 6 | 1 |
Collected over Date treatment consent signed to date off study, approximately 110 months and 27 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 11/12 (91.7%) | 0/12 (0%) | 12/12 (100%) |
| 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 3/6 (50%) | 0/6 (0%) | 6/6 (100%) |
| 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 3/12 | 1/6 | 1/1 |
| Aspartate aminotransferase increasedInvestigations | 3/12 | 1/6 | 1/1 |
| Blood bilirubin increasedInvestigations | 1/12 | 0/6 | 1/1 |
| Investigations - Other, Blood lactate dehydrogenase increasedInvestigations | 0/12 | 0/6 | 1/1 |
| Lymphocyte count increasedInvestigations | 1/12 | 1/6 | 1/1 |
| Neutrophil count decreasedInvestigations | 6/12 | 3/6 | 1/1 |
| Platelet count decreasedInvestigations | 2/12 | 0/6 | 1/1 |
| White blood cell decreasedInvestigations | 7/12 | 0/6 | 1/1 |
| Lymphocyte count decreasedInvestigations | 7/12 | 2/6 | 0/1 |
| Alanine aminotransferase increasedInvestigations | 3/12 | 2/6 | 0/1 |
| Age, Categorical(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 6 | 1 | 17 |
| >=65 years | 2 | 0 | 0 | 2 |
| Age, Continuous(years) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| Mean | 44.5 ± 14.5 | 46.3 ± 10.9 | 65 ± 0 | 51.93 ± 12.7 |
| Sex: Female, Male(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| Female | 5 | 3 | 1 | 9 |
| Male | 7 | 3 | 0 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 6 | 1 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 12 | 5 | 1 | 18 |
| White | 0 | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| United States | 12 | 6 | 1 | 19 |
| Adult T-Cell Leukemia Lymphoma Diagnosis(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| Count of participants | 12 | 6 | 1 | 19 |
| Performance Status(Participants) | Original Phase II Standard Ruxolitinib Dose Cohort - 20 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 1 - 30 mg Twice Daily | 2- Phase 1 Dose Escalation Cohorts Dose Level 2 - 40 mg Twice Daily | Total |
|---|---|---|---|---|
| 0 | 5 | 4 | 0 | 9 |
| 1 | 7 | 2 | 1 | 10 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely.
Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ruxolitinib
Leukemia-Lymphoma, Adult T-Cell →
National Cancer Institute (NCI) →