Trial Outcomes & Findings for A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial) (NCT NCT02091752)

NCT ID: NCT02091752

Last Updated: 2016-03-24

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2016-03-24

Participant Flow

Participant milestones

Measure	Ruxolitinib All participants received ruxolitinib.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Ruxolitinib All participants received ruxolitinib.
Overall Study Study terminated by Sponsor	2
Overall Study Adverse Event	1

Baseline Characteristics

A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

Baseline characteristics by cohort

Measure	Ruxolitinib n=3 Participants All participants received ruxolitinib.
Age, Continuous	68.00 Years STANDARD_DEVIATION 9.165 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1, Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 1, Week 8, Week 12, Week 16, Week 24

Population: The study was terminated early due to low enrollment. Analysis was not done.

Outcome measures

Outcome data not reported

Adverse Events

Ruxolitinib

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ruxolitinib n=3 participants at risk All participants received ruxolitinib.
Gastrointestinal disorders CONSTIPATION	33.3% 1/3
Immune system disorders CYTOKINE RELEASE SYNDROME	33.3% 1/3
Infections and infestations LISTERIOSIS	33.3% 1/3
Renal and urinary disorders RENAL FAILURE	33.3% 1/3

Other adverse events

Measure	Ruxolitinib n=3 participants at risk All participants received ruxolitinib.
Blood and lymphatic system disorders ANAEMIA	33.3% 1/3
Gastrointestinal disorders ANAL HAEMORRHAGE	33.3% 1/3
Gastrointestinal disorders ASCITES	33.3% 1/3
Gastrointestinal disorders CONSTIPATION	33.3% 1/3
Gastrointestinal disorders DIARRHOEA	33.3% 1/3
Gastrointestinal disorders VARICES OESOPHAGEAL	33.3% 1/3
Hepatobiliary disorders PORTAL VEIN THROMBOSIS	33.3% 1/3
Infections and infestations CYSTITIS	33.3% 1/3
Investigations ALANINE AMINOTRANSFERASE INCREASED	33.3% 1/3
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	33.3% 1/3

Additional Information

Study Director

Novartis

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER