Trial Outcomes & Findings for Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD (NCT NCT04446182)

Last Updated: 2024-01-22

Results Overview

Adverse events were assessed at each study visit from the first dose of itacitinib during the lead-in period (lead-in period = 5-10 days) until the last day of cycle one (each cycle = 28 days) of combination treatment with itacitinib and Extracorporeal Photopheresis (ECP). A DLT was defined as an Adverse Event (AE) that was 1) attributed as possibly, probably, or definitely related to itacitinib or to the combination of itacitinib and ECP, and 2) graded as "severe" or "life threatening" (grade 3 or 4) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

up to 38 days

Results posted on

2024-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment: All Participants (Dose Level 1, Starting Dose) Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion. Though this study was initially conceived as a dose de-escalation study, the study was terminated with three participants accrued, meaning all patients received the starting dose of 200 mg daily, days 1-28 per cycle, per the 3+3 dose de-escalation study design. Thus, only one treatment arm is appropriate in reporting study results.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61.33 years STANDARD_DEVIATION 12.71 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Mean Baseline NIH Global GVHD Score	2 score on a scale STANDARD_DEVIATION 0 • n=5 Participants
Mean clinician-assessed NIH GVHD severity score	4.67 score on a scale STANDARD_DEVIATION .58 • n=5 Participants
Mean participant-assessed NIH GVHD severity score	6.33 score on a scale STANDARD_DEVIATION 0.58 • n=5 Participants

PRIMARY outcome

Timeframe: up to 38 days

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With a Dose-limiting Toxicity (DLT) During the DLT Evaluation Period.	0 Participants

PRIMARY outcome

Timeframe: 24 weeks

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline and after 24 weeks of treatment. The criteria evaluates 9 organ systems, and then defines a partial response (PR) as at least one organ system with improvement since baseline and no worsening in other organs. Complete response (CR) is defined as an improvement in all affected organ systems to having no GVHD symptoms in any organ system. All responses must occur without any secondary systemic immunosuppressive therapy, and no malignancy recurrence or death. Participants with a PR or CR are counted as a response for this outcome.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With a Response to Treatment at 24 Weeks of Treatment	2 Participants

SECONDARY outcome

Timeframe: during study treatment - up to 1 year

Adverse events were assessed at each study visit per CTCAE v5 criteria. This objective counts the number of participants who experienced 1) any adverse event of any severity, or 2) any serious adverse event that was possibly, probably, or definitely related to itacitinib or to combination treatment with itacitinib and ECP.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) During Study Treatment Serious Adverse Events	1 Participants
Count of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) During Study Treatment Adverse Events	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Only one participant was assessed at the one year time point. The others had discontinued treatment prior to that time point.

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline and after one year of treatment. The criteria evaluates 9 organ systems, and then defines a partial response (PR) as at least one organ system with improvement since baseline and no worsening in other organs. Complete response (CR) is defined as an improvement in all affected organ systems to having no GVHD symptoms in any organ system. All responses must occur without any secondary systemic immunosuppressive therapy, and no malignancy recurrence or death. Participants with a PR or CR are counted as a response for this outcome.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=1 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With a Response to Treatment After One Year of Treatment	0 Participants

SECONDARY outcome

Timeframe: 24 weeks and 1 year

Failure Free Survival (FFS) is defined as the number of participants at 24 weeks and at 1 year who have not experienced treatment failure. Treatment failure is defined as the initiation of secondary therapy for chronic GVHD, malignancy relapse, or death from any cause.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With Failure Free Survival (FFS) at 24 Weeks and 1 Year FFS at 24 weeks	3 Participants
Count of Participants With Failure Free Survival (FFS) at 24 Weeks and 1 Year FFS at 1 year	2 Participants

SECONDARY outcome

Timeframe: 1 year

Immunosuppressive therapy is common for participants with GVHD. This objective counts the number of participants who were able to discontinue all immunosuppressants by 1 year of treatment and follow-up.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants Who Have Withdrawn All Immunosuppressants at 1 Year	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Two participants, both at the 0 mg/kg/d prednisone use, were assessed for this measure at 24 weeks. The other had discontinued treatment prior to that time point.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=2 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With a Response to Treatment at 24 Weeks of Treatment Stratified by Concurrent Prednisone Use 0 mg/kg/d prednisone use	2 Participants
Count of Participants With a Response to Treatment at 24 Weeks of Treatment Stratified by Concurrent Prednisone Use ≤ 0.25mg/kg/d prednisone use	0 Participants
Count of Participants With a Response to Treatment at 24 Weeks of Treatment Stratified by Concurrent Prednisone Use > 0.25mg/kg/d prednisone use	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

This outcome assessed the cumulative amount of prednisone (or other steroids converted to prednisone equivalence) used by participants up to 24 weeks of treatment.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Mean Cumulative Prednisone Used up to 24 Weeks	30 milligrams Standard Deviation 42.426

SECONDARY outcome

Timeframe: 24 weeks

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline and after 24 weeks of treatment. The criteria evaluate 9 organ systems, and for each organ, defines changes in symptoms to qualify as a partial response (PR), complete response (CR), or progressive disease (PD) in that organ. In general, PR in an organ indicates partial improvement after prior involvement of that organ. CR indicates improvement to no symptoms after prior involvement. PD indicates worsening of symptoms in the organ system. Lack of response indicates that the organ system was involved at both baseline and 24 weeks, but did not improve or deteriorate sufficiently to qualify for PR, CR, or PD. No involvement/Not evaluable indicates that the organ system never had any GVHD symptoms or was not able to be evaluated.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With Organ-specific Responses at 24 Weeks Mouth · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Mouth · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Mouth · Complete Response	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Mouth · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Mouth · No involvement/Not evaluable	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Eyes · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Eyes · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Eyes · Complete Response	1 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Eyes · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Eyes · No involvement/Not evaluable	2 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Skin · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Skin · Partial Response	2 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Skin · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Skin · Lack of response	1 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Skin · No involvement/Not evaluable	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Esophagus · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Esophagus · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Esophagus · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Esophagus · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Esophagus · No involvement/Not evaluable	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Upper GI · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Upper GI · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Upper GI · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Upper GI · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Upper GI · No involvement/Not evaluable	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lower GI · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lower GI · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lower GI · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lower GI · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lower GI · No involvement/Not evaluable	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Liver · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Liver · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Liver · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Liver · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Liver · No involvement/Not evaluable	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lungs · Progression	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lungs · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lungs · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lungs · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Lungs · No involvement/Not evaluable	3 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Joints and facia · Progression	1 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Joints and facia · Partial Response	2 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Joints and facia · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Joints and facia · Lack of response	0 Participants
Count of Participants With Organ-specific Responses at 24 Weeks Joints and facia · No involvement/Not evaluable	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Only one participant completed 1 year of treatment to be evaluated for this outcome.

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline and after 1 year of treatment. The criteria evaluate 9 organ systems, and for each organ, defines changes in symptoms to qualify as a partial response (PR), complete response (CR), or progressive disease (PD) in that organ. In general, PR in an organ indicates partial improvement after prior involvement of that organ. CR indicates improvement to no symptoms after prior involvement. PD indicates worsening of symptoms in the organ system. Lack of response indicates that the organ system was involved at both baseline and 24 weeks, but did not improve or deteriorate sufficiently to qualify for PR, CR, or PD. No involvement indicates that the organ system never had any GVHD symptoms.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=1 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With Organ-specific Responses at 1 Year Eyes · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Esophagus · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Mouth · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Mouth · Partial Response	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Mouth · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Mouth · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Mouth · No involvement/Not evaluable	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Eyes · Progression	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Eyes · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Eyes · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Eyes · No involvement/Not evaluable	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Skin · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Skin · Partial Response	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Skin · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Skin · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Skin · No involvement/Not evaluable	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Esophagus · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Esophagus · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Esophagus · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Esophagus · No involvement/Not evaluable	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Upper GI · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Upper GI · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Upper GI · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Upper GI · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Upper GI · No involvement/Not evaluable	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Lower GI · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lower GI · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lower GI · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lower GI · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lower GI · No involvement/Not evaluable	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Liver · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Liver · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Liver · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Liver · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Liver · No involvement/Not evaluable	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Lungs · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lungs · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lungs · Complete Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lungs · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Lungs · No involvement/Not evaluable	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Joints and facia · Progression	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Joints and facia · Partial Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Joints and facia · Complete Response	1 Participants
Count of Participants With Organ-specific Responses at 1 Year Joints and facia · Lack of Response	0 Participants
Count of Participants With Organ-specific Responses at 1 Year Joints and facia · No involvement/Not evaluable	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline and after 24 weeks of treatment. One data point in the criteria is an overall global rating of the participant's GVHD, ranging from 0 (no GVHD) to 3 (severe GVHD). The baseline global score is reported in the baseline characteristics.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Mean NIH Global GVHD Score at 24 Weeks	1.67 score on a scale Standard Deviation .58

SECONDARY outcome

Timeframe: up to 1 year

Population: Two participants had a partial response or better.

DOR was measured as the interval between the date of initial documentation of a response (PR or better), and the date of progression, start of a new therapy for chronic GVHD (cGVHD) (including corticosteroids), or death from any cause.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=2 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Duration of Response (DOR)	119.5 days Standard Deviation 93.5

SECONDARY outcome

Timeframe: at 24 weeks and 1 year

Population: Only one participant continued treatment long enough to be evaluated at 1 year.

Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline, after 24 weeks of treatment, and after one year of treatment. One data point in the criteria is a general rating the severity of the participant's GVHD symptoms, ranging from 0 (GVHD symptoms not at all severe) to 10 (most severe GVHD symptoms possible). The baseline severity score is reported in the baseline characteristics.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Mean Clinician-evaluated GVHD Severity Score at 24 Weeks and 1 Year Severity score at 24 weeks	4 score on a scale Standard Deviation 1.73
Mean Clinician-evaluated GVHD Severity Score at 24 Weeks and 1 Year Severity score at 1 year	3 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 24 weeks and 1 year

Population: One participant did not complete the cGVHD severity assessment at week 24. Two participants did not continue treatment long enough to self-assess for cGVHD severity at one year.

Participants were asked to rate their own symptoms for chronic graft versus host disease (cGVHD) severity per the NIH Consensus Development Project Criteria at baseline, after 24 weeks of treatment, and after one year of treatment. One data point in is a general rating of the severity of the participant's GVHD symptoms, ranging from 0 (GVHD symptoms not at all severe) to 10 (most severe GVHD symptoms possible). The baseline severity score is reported in the baseline characteristics.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=2 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Mean Participant-reported cGVHD Symptom Severity Score at 24 Weeks and at 1 Year Severity score at 24 weeks	6 score on a scale Standard Deviation 1.41
Mean Participant-reported cGVHD Symptom Severity Score at 24 Weeks and at 1 Year Severity score at 1 year	5 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 24 weeks and 1 year

NRM is defined as death due to causes other than a relapse of their primary hematologic disease. This outcome reports the number of participants who were deceased at 24 weeks and at 1 year after the start of treatment whose death meets the definition of NRM.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With Non-relapse Mortality (NRM) NRM at 24 weeks	0 Participants
Count of Participants With Non-relapse Mortality (NRM) NRM at 1 year	0 Participants

SECONDARY outcome

Timeframe: 24 weeks and 1 year

Relapse is defined as re-activation of the participant's primary hematologic malignancy after it has been in remission. This outcome reports the number of participants who had experienced relapse at 24 weeks and at 1 year after start of treatment.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants With Relapse at 24 Weeks and 1 Year Relapse at 24 weeks	0 Participants
Count of Participants With Relapse at 24 Weeks and 1 Year Relapse at 1 year	0 Participants

SECONDARY outcome

Timeframe: 24 weeks and 1 year

This outcome measures overall survival (OS), meaning the number of participants who remain alive at 24 weeks and at 1 year from start of treatment.

Outcome measures

Outcome measures
Measure	Treatment: All Participants n=3 Participants Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Count of Participants Alive at 24 Weeks and 1 Year Overall Survival at 24 weeks	3 Participants
Count of Participants Alive at 24 Weeks and 1 Year Overall Survival at 1 year	3 Participants

Adverse Events

Treatment: All Participants

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment: All Participants n=3 participants at risk Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Respiratory, thoracic and mediastinal disorders Lung infection	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.

Other adverse events

Other adverse events
Measure	Treatment: All Participants n=3 participants at risk Participants will begin with a 5-10 lead-in period of self-administered itacitinib, after which they will continue itacitinib for 6 28 day cycles. Extracorporeal Photopheresis (ECP) will begin on Cycle 1 Day 1 after the lead-in period, and will be administered twice weekly on consecutive days for 8 weeks. At the end of 8 weeks (2 cycles) of combination therapy, participants will start a standard ECP taper schedule and itacitinib will be continued at the assigned dose level. After six cycles of therapy, itacitinib may be tapered at the treating investigator's discretion.
Eye disorders Dry eye	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Eye disorders Watering eyes	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Gastrointestinal disorders Colitis	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 4 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
General disorders Chills	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
General disorders Edema limbs	66.7% 2/3 • Number of events 2 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
General disorders Fatigue	66.7% 2/3 • Number of events 3 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
General disorders Flu like symptoms	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 2 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Infections and infestations Thrush	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Infections and infestations Vaginal infection	50.0% 1/2 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Injury, poisoning and procedural complications Fall	66.7% 2/3 • Number of events 2 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Injury, poisoning and procedural complications Hip fracture	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Investigations Creatinine increased	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Metabolism and nutrition disorders Hyperphosphatemia	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Musculoskeletal and connective tissue disorders Arthritis	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Musculoskeletal and connective tissue disorders Muscle cramp	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Nervous system disorders Paresthesia	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Renal and urinary disorders Urinary frequency	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Erythema multiforme	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Pain of skin	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	100.0% 3/3 • Number of events 6 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Skin and subcutaneous tissue disorders Skin ulceration	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Collection of serious adverse events will begin at the initiation of study treatment and end 30 days after the last dose of study treatment or until new cancer treatment is initiated, whichever happens the soonest. For this study, actual treatment ranged from 181 days to 350 days with a median of 203 days. Adverse events were reviewed with the participant and the investigator at every study visit. All adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, were collected.

Additional Information

Clinicaltrials.gov/CTRP Specialist

Huntsman Cancer Institute/University of Utah

Phone: 8012136215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place