CINC424A2X01B Rollover Protocol

Novartis

Status and phase: Active, not recruiting; Phase 4

Conditions: Graft Versus Host Disease; Thalassemia; Polycythemia Vera; Primary Myelofibrosis; Acute Myeloid Leukemia

Treatments: Drug: panobinostat; Drug: ruxolitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386800

2014-003527-22 (EudraCT Number)

CINC424A2X01B

Details and patient eligibility

About

This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.

Full description

This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.

Enrollment: 279 patients

Sex: All

Ages: 1 month to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion criteria:

1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat

Key Exclusion criteria:

1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.
2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
3. Pregnant or nursing (lactating) women.
4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.

Other protocol-defined Inclusion / Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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279 participants in 1 patient group

Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination

Experimental group

Description:

All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.

Treatment:

Drug: ruxolitinib

Drug: panobinostat