Study: NCT03112603

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib
Description: Ruxolitinib twice daily at the protocol-defined starting dose.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Extracorporeal photopheresis (ECP)
Description: Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Low-dose methotrexate (MTX)
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolate mofetil (MMF)
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Infliximab
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pentostatin
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Imatinib
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ibrutinib
Description: Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.