A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

• ClinicalTrials.gov Identifier: NCT02953678
• Recruitment Status: Completed
• First Posted: November 3, 2016
• Results First Posted: August 20, 2019
• Last Update Posted: November 24, 2021
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Graft-versus-host Disease (GVHD)
• Interventions: Drug: Ruxolitinib; Drug: Prednisone or methylprednisolone
• Enrollment: 71

Participant Flow

Recruitment Details	This study was conducted at 26 study centers in the United States.
Pre-assignment Details

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description	Participants began oral administration of ruxolitinib at 5 mg twice a day (BID); if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Period Title: Overall Study
Started	71
Completed	0
Not Completed	71
Reason Not Completed
Adverse Event	20
Death	7
Physician Decision	23
Progressive Disease of GVHD	7
Relapse of Underlying Malignancy	3
Withdrawal by participant	3
Includes 2 participants who discontinued ruxolitinib treatment because of clinical improvement	5
Participants were transferred to commercial product.	3

Baseline Characteristics

Arm/Group Title		Ruxolitinib in Combination With Corticosteroids
Arm/Group Description		Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Baseline Participants		71
Baseline Analysis Population Description		The efficacy evaluable population included all participants enrolled in the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	71 participants
		52.9 (14.18)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
< 65 years	Number Analyzed	71 participants
		58 81.7%
≥ 65 years	Number Analyzed	71 participants
		13 18.3%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants
	Female	36 50.7%
	Male	35 49.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants
	Hispanic or Latino	9 12.7%
	Not Hispanic or Latino	60 84.5%
	Unknown or Not Reported	2 2.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 2.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 4.2%
	White	66 93.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Height [1]; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	66 participants
		170.2 (10.64)
		[1] Measure Analysis Population Description: Height was not obtained for 5 participants.
Weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	71 participants
		78.64 (21.651)
Body Mass Index (BMI) [1]; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	66 participants
		26.83 (6.193)
		[1] Measure Analysis Population Description: Height was not obtained for 5 participants; BMI could not be calculated for these participants.
Body Surface Area (BSA) [1]; Mean (Standard Deviation); Unit of measure: M^2
	Number Analyzed	66 participants
		1.91 (0.301)
		[1] Measure Analysis Population Description: Height was not obtained for 5 participants; BSA could not be calculated for these participants.
Eastern Cooperative Oncology Group (ECOG) grade at baseline [1]; Measure Type: Count of Participants; Unit of measure: Participants
ECOG - 0	Number Analyzed	71 participants
		3 4.2%
ECOG - 1	Number Analyzed	71 participants
		24 33.8%
ECOG - 2	Number Analyzed	71 participants
		25 35.2%
ECOG - 3	Number Analyzed	71 participants
		17 23.9%
ECOG - 4	Number Analyzed	71 participants
		1 1.4%
ECOG - 5	Number Analyzed	71 participants
		0 0.0%
Missing	Number Analyzed	71 participants
		1 1.4%
		[1] Measure Description: ECOG scores are from 0-5: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 = dead.

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR) at Day 28
Description	Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Time Frame	From baseline to Day 28

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Measure Type: Count of Participants; Unit of Measure: Participants
Responders - CR	19 26.8%
Responders - VGPR	7 9.9%
Responders - PR	13 18.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ruxolitinib in Combination With Corticosteroids
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Exact method for binomial distributions
	Estimated Value	54.9
	Confidence Interval	(2-Sided) 95%; 42.7 to 66.8
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Overall Response Rate (ORR)
Description	Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
Time Frame	From baseline to days 14, 56, and 100

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Population included all participants enrolled in this study.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed	71
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 14	62.0; (49.7 to 73.2)
Day 56	36.6; (25.5 to 48.9)
Day 100	32.4; (21.8 to 44.5)

3. Secondary Outcome

Title	Nonrelapse Mortality (NRM)
Description	Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Time Frame	From baseline to Months 6, 9, 12, and 24

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
6 months	44.4; (32.5 to 55.7)
9 months	48.2; (35.8 to 59.5)
12 months	52.9; (39.6 to 64.5)
24 months	64.8; (46.0 to 78.5)

4. Secondary Outcome

Title	Percentage of Participants With Six-month Duration of Response (DOR)
Description	Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit.
Time Frame	From Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed	40
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	68.2; (49.6 to 81.2)

5. Secondary Outcome

Title	Percentage of Participants With Three-month DOR
Description	Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit.
Time Frame	From Baseline up to 3 months

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed	40
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	84.5; (68.7 to 92.7)

6. Secondary Outcome

Title	Relapse Rate
Description	Defined as the percentage of participants whose underlying malignancy relapsed.
Time Frame	From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Population included all participants enrolled in this study.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7.0; (2.3 to 15.7)

7. Secondary Outcome

Title	Relapse-related Mortality Rate
Description	Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.
Time Frame	From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Population included all participants enrolled in this study.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	5.6; (1.6 to 13.8)

8. Secondary Outcome

Title	Failure-free Survival (FFS)
Description	Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
Time Frame	From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Participants

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Median (95% Confidence Interval); Unit of Measure: days
	85.0; (42.0 to 158.0)

9. Secondary Outcome

Title	Overall Survival (OS)
Description	Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.
Time Frame	From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable Participants: Participants who had CR, VGPR, or PR on or before the start of new anti-GVHD therapy.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
Overall Number of Participants Analyzed	71
Median (95% Confidence Interval); Unit of Measure: days
	232.0; (93.0 to 675.0)

10. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
Description	AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event.
Time Frame	From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

Outcome Measure Data

Analysis Population Description

Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.

Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description:	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
Overall Number of Participants Analyzed	71
Measure Type: Count of Participants; Unit of Measure: Participants
TEAEs	71 100.0%
Serious TEAEs	59 83.1%
Grade 3 or Higher TEAEs	69 97.2%

Adverse Events

Time Frame	From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
Adverse Event Reporting Description	The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.
Arm/Group Title	Ruxolitinib in Combination With Corticosteroids
Arm/Group Description	Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
All-Cause Mortality
	Ruxolitinib in Combination With Corticosteroids
	Affected / at Risk (%)
Total	46/71 (64.79%)
Serious Adverse Events
	Ruxolitinib in Combination With Corticosteroids
	Affected / at Risk (%)
Total	59/71 (83.10%)
Blood and lymphatic system disorders
Anaemia † 1	2/71 (2.82%)
Thrombocytopenia † 1	1/71 (1.41%)
Cardiac disorders
Cardiac arrest † 1	1/71 (1.41%)
Myocardial infarction † 1	2/71 (2.82%)
Palpitations † 1	1/71 (1.41%)
Pulseless electrical activity † 1	1/71 (1.41%)
Supraventricular tachycardia † 1	1/71 (1.41%)
Eye disorders
Blindness † 1	1/71 (1.41%)
Eye disorder † 1	1/71 (1.41%)
Gastrointestinal disorders
Abdominal pain † 1	1/71 (1.41%)
Abdominal pain upper † 1	1/71 (1.41%)
Diarrhoea † 1	3/71 (4.23%)
Dysphagia † 1	1/71 (1.41%)
Gastritis † 1	1/71 (1.41%)
Gastrointestinal haemorrhage † 1	1/71 (1.41%)
Lower gastrointestinal haemorrhage † 1	2/71 (2.82%)
Nausea † 1	2/71 (2.82%)
Pneumatosis intestinalis † 1	4/71 (5.63%)
Retroperitoneal haematoma † 1	1/71 (1.41%)
Small intestinal haemorrhage † 1	1/71 (1.41%)
Toothache † 1	1/71 (1.41%)
Upper gastrointestinal haemorrhage † 1	1/71 (1.41%)
Vomiting † 1	2/71 (2.82%)
Enterocolitis † 1	1/71 (1.41%)
General disorders
Multiple organ dysfunction syndrome † 1	2/71 (2.82%)
Pain † 1	1/71 (1.41%)
Pyrexia † 1	8/71 (11.27%)
Sudden death † 1	1/71 (1.41%)
Disease progression † 1	2/71 (2.82%)
Fatigue † 1	1/71 (1.41%)
Influenza like illness † 1	1/71 (1.41%)
Hepatobiliary disorders
Cholecystitis acute † 1	1/71 (1.41%)
Hepatic failure † 1	2/71 (2.82%)
Venoocclusive liver disease † 1	1/71 (1.41%)
Cholecystitis † 1	1/71 (1.41%)
Liver injury † 1	1/71 (1.41%)
Immune system disorders
Acute graft versus host disease † 1	1/71 (1.41%)
Graft versus host disease in gastrointestinal tract † 1	1/71 (1.41%)
Graft versus host disease in liver † 1	1/71 (1.41%)
Infections and infestations
Bacteraemia † 1	4/71 (5.63%)
Bronchopulmonary aspergillosis † 1	1/71 (1.41%)
Candida infection † 1	1/71 (1.41%)
Cellulitis † 1	1/71 (1.41%)
Citrobacter infection † 1	1/71 (1.41%)
Cystitis † 1	1/71 (1.41%)
Cytomegalovirus viraemia † 1	1/71 (1.41%)
Device related infection † 1	2/71 (2.82%)
Enterococcal infection † 1	1/71 (1.41%)
Enterocolitis infectious † 1	1/71 (1.41%)
Escherichia urinary tract infection † 1	1/71 (1.41%)
Fungaemia † 1	1/71 (1.41%)
Hepatic infection fungal † 1	1/71 (1.41%)
Influenza † 1	2/71 (2.82%)
Klebsiella bacteraemia † 1	1/71 (1.41%)
Lung infection † 1	5/71 (7.04%)
Mycotic endophthalmitis † 1	1/71 (1.41%)
Peritonitis † 1	1/71 (1.41%)
Pneumonia † 1	5/71 (7.04%)
Pneumonia bacterial † 1	1/71 (1.41%)
Pneumonia legionella † 1	1/71 (1.41%)
Respiratory syncytial virus infection † 1	1/71 (1.41%)
Sepsis † 1	9/71 (12.68%)
Septic shock † 1	3/71 (4.23%)
Sialoadenitis † 1	1/71 (1.41%)
Sinusitis † 1	1/71 (1.41%)
Staphylococcal bacteraemia † 1	2/71 (2.82%)
Staphylococcal infection † 1	1/71 (1.41%)
Staphylococcal sepsis † 1	1/71 (1.41%)
Urinary tract infection † 1	1/71 (1.41%)
Enterococcal sepsis † 1	1/71 (1.41%)
Upper respiratory tract infection † 1	1/71 (1.41%)
Injury, poisoning and procedural complications
Fall † 1	1/71 (1.41%)
Hip fracture † 1	1/71 (1.41%)
Road traffic accident † 1	1/71 (1.41%)
Vascular access complication † 1	1/71 (1.41%)
Investigations
Alanine aminotransferase increased † 1	1/71 (1.41%)
Aspartate aminotransferase increased † 1	1/71 (1.41%)
Neutrophil count decreased † 1	1/71 (1.41%)
Platelet count decreased † 1	2/71 (2.82%)
Metabolism and nutrition disorders
Failure to thrive † 1	2/71 (2.82%)
Hyperglycaemia † 1	1/71 (1.41%)
Hypokalaemia † 1	1/71 (1.41%)
Hyponatraemia † 1	2/71 (2.82%)
Musculoskeletal and connective tissue disorders
Back pain † 1	1/71 (1.41%)
Groin pain † 1	1/71 (1.41%)
Muscular weakness † 1	2/71 (2.82%)
Osteonecrosis † 1	1/71 (1.41%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent † 1	1/71 (1.41%)
Transitional cell carcinoma † 1	1/71 (1.41%)
Nervous system disorders
Encephalopathy † 1	1/71 (1.41%)
Headache † 1	2/71 (2.82%)
Syncope † 1	1/71 (1.41%)
Psychiatric disorders
Confusional state † 1	1/71 (1.41%)
Mental status changes † 1	3/71 (4.23%)
Suicidal ideation † 1	1/71 (1.41%)
Renal and urinary disorders
Acute kidney injury † 1	4/71 (5.63%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † 1	1/71 (1.41%)
Pulmonary haemorrhage † 1	1/71 (1.41%)
Respiratory failure † 1	7/71 (9.86%)
Vascular disorders
Deep vein thrombosis † 1	1/71 (1.41%)
Hypotension † 1	2/71 (2.82%)
1 Term from vocabulary, MedDRA 19.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ruxolitinib in Combination With Corticosteroids
	Affected / at Risk (%)
Total	69/71 (97.18%)
Blood and lymphatic system disorders
Anaemia † 1	45/71 (63.38%)
Neutropenia † 1	6/71 (8.45%)
Thrombocytopenia † 1	13/71 (18.31%)
Cardiac disorders
Pericardial effusion † 1	7/71 (9.86%)
Sinus tachycardia † 1	14/71 (19.72%)
Eye disorders
Dry eye † 1	11/71 (15.49%)
Vision blurred † 1	8/71 (11.27%)
Gastrointestinal disorders
Abdominal distension † 1	11/71 (15.49%)
Abdominal pain † 1	15/71 (21.13%)
Ascites † 1	6/71 (8.45%)
Constipation † 1	13/71 (18.31%)
Diarrhoea † 1	20/71 (28.17%)
Dry mouth † 1	11/71 (15.49%)
Dyspepsia † 1	5/71 (7.04%)
Dysphagia † 1	5/71 (7.04%)
Flatulence † 1	11/71 (15.49%)
Gastrooesophageal reflux disease † 1	4/71 (5.63%)
Haemorrhoids † 1	7/71 (9.86%)
Lower gastrointestinal haemorrhage † 1	10/71 (14.08%)
Nausea † 1	23/71 (32.39%)
Stomatitis † 1	5/71 (7.04%)
Vomiting † 1	16/71 (22.54%)
General disorders
Chills † 1	8/71 (11.27%)
Fatigue † 1	22/71 (30.99%)
Malaise † 1	6/71 (8.45%)
Non-cardiac chest pain † 1	7/71 (9.86%)
Oedema † 1	4/71 (5.63%)
Oedema peripheral † 1	33/71 (46.48%)
Pyrexia † 1	11/71 (15.49%)
Pain † 1	4/71 (5.63%)
Immune system disorders
Hypogammaglobulinaemia † 1	5/71 (7.04%)
Infections and infestations
BK virus infection † 1	5/71 (7.04%)
Cytomegalovirus infection † 1	9/71 (12.68%)
Cytomegalovirus viraemia † 1	4/71 (5.63%)
Enterococcal infection † 1	6/71 (8.45%)
Staphylococcal infection † 1	4/71 (5.63%)
Urinary tract infection † 1	6/71 (8.45%)
Upper Respiratory Tract Infection † 1	6/71 (8.45%)
Injury, poisoning and procedural complications
Contusion † 1	5/71 (7.04%)
Fall † 1	14/71 (19.72%)
Investigations
Alanine aminotransferase increased † 1	18/71 (25.35%)
Aspartate aminotransferase increased † 1	17/71 (23.94%)
Blood alkaline phosphatase increased † 1	9/71 (12.68%)
Blood bilirubin increased † 1	11/71 (15.49%)
Blood creatinine increased † 1	13/71 (18.31%)
International normalised ratio increased † 1	7/71 (9.86%)
Lymphocyte count decreased † 1	8/71 (11.27%)
Neutrophil count decreased † 1	27/71 (38.03%)
Platelet count decreased † 1	32/71 (45.07%)
Weight decreased † 1	7/71 (9.86%)
White blood cell count decreased † 1	21/71 (29.58%)
Metabolism and nutrition disorders
Acidosis † 1	6/71 (8.45%)
Decreased appetite † 1	16/71 (22.54%)
Dehydration † 1	5/71 (7.04%)
Hyperglycaemia † 1	17/71 (23.94%)
Hyperkalaemia † 1	8/71 (11.27%)
Hypermagnesaemia † 1	6/71 (8.45%)
Hypertriglyceridaemia † 1	9/71 (12.68%)
Hypoalbuminaemia † 1	13/71 (18.31%)
Hypocalcaemia † 1	22/71 (30.99%)
Hypoglycaemia † 1	10/71 (14.08%)
Hypokalaemia † 1	34/71 (47.89%)
Hypomagnesaemia † 1	24/71 (33.80%)
Hyponatraemia † 1	13/71 (18.31%)
Hypophosphataemia † 1	19/71 (26.76%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	13/71 (18.31%)
Back pain † 1	16/71 (22.54%)
Muscular weakness † 1	24/71 (33.80%)
Musculoskeletal pain † 1	4/71 (5.63%)
Myalgia † 1	5/71 (7.04%)
Pain in extremity † 1	12/71 (16.90%)
Nervous system disorders
Dizziness † 1	10/71 (14.08%)
Dysgeusia † 1	4/71 (5.63%)
Encephalopathy † 1	4/71 (5.63%)
Headache † 1	13/71 (18.31%)
Lethargy † 1	5/71 (7.04%)
Paraesthesia † 1	4/71 (5.63%)
Peripheral sensory neuropathy † 1	4/71 (5.63%)
Somnolence † 1	6/71 (8.45%)
Syncope † 1	4/71 (5.63%)
Tremor † 1	7/71 (9.86%)
Psychiatric disorders
Anxiety † 1	10/71 (14.08%)
Confusional state † 1	9/71 (12.68%)
Delirium † 1	6/71 (8.45%)
Depression † 1	11/71 (15.49%)
Hallucination † 1	4/71 (5.63%)
Insomnia † 1	10/71 (14.08%)
Renal and urinary disorders
Acute kidney injury † 1	13/71 (18.31%)
Haematuria † 1	12/71 (16.90%)
Micturition urgency † 1	4/71 (5.63%)
Pollakiuria † 1	10/71 (14.08%)
Urinary incontinence † 1	6/71 (8.45%)
Urinary retention † 1	4/71 (5.63%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	15/71 (21.13%)
Dyspnoea † 1	24/71 (33.80%)
Epistaxis † 1	8/71 (11.27%)
Hiccups † 1	4/71 (5.63%)
Hypoxia † 1	7/71 (9.86%)
Nasal congestion † 1	8/71 (11.27%)
Pleural effusion † 1	9/71 (12.68%)
Productive cough † 1	5/71 (7.04%)
Oropharyngeal pain † 1	4/71 (5.63%)
Skin and subcutaneous tissue disorders
Dry skin † 1	7/71 (9.86%)
Erythema † 1	4/71 (5.63%)
Pruritus † 1	4/71 (5.63%)
Rash † 1	6/71 (8.45%)
Rash maculo-papular † 1	9/71 (12.68%)
Vascular disorders
Hypertension † 1	16/71 (22.54%)
Hypotension † 1	14/71 (19.72%)
1 Term from vocabulary, MedDRA 19.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.

Results Point of Contact

• Name/Title: Study Director
• Organization: Incyte Corporation
• Phone: 1-855-463-3463
• EMail: medinfo@incyte.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jagasia M, Perales MA, Schroeder MA, Ali H, Shah NN, Chen YB, Fazal S, Dawkins FW, Arbushites MC, Tian C, Connelly-Smith L, Howell MD, Khoury HJ. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14;135(20):1739-1749. doi: 10.1182/blood.2020004823.

Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT02953678
• Other Study ID Numbers: INCB 18424-271 (REACH-1)
• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Results First Submitted: June 24, 2019
• Results First Posted: August 20, 2019
• Last Update Posted: November 24, 2021